Quality Assurance Job Description Sample
Head, Pharmacovigilance Quality Assurance And LOC Medical Quality Assurance
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Head of Pharmacovigilance Quality Assurance and LOC Medical Quality Assurance in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As the Head of the Pharmacovigilance Quality Assurance and LOC Medical Quality Assurance team, you will be empowered to lead the function, and a typical day will include: POSITION OBJECTIVES: * Lead and optimize the Pharmacovigilance Quality Assurance function and LOC Medical Quality Assurance function, with quality assurance oversight of Takeda Global Patient Safety Evaluation and of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) activities conducted by Local Operating Companies (LOCs).
Define and articulate the strategy for GVP and GCP (at LOCs) oversight, in close collaboration with the Global Patient Safety Evaluation, Global Medical Affairs and Commercial Quality functions.
In close collaboration with R&D Quality Systems and Compliance, ensure that all processes implemented by Pharmacovigilance and LOC medical functions meet or exceed regulatory requirements, industry standards, and Takeda requirements.
Report to the Head of Research and Development Quality, and serve as a member of the Research and Development Quality Leadership Team (RDQLT). POSITION ACCOUNTABILITIES: * Lead and optimize the Pharmacovigilance Quality Assurance function, ensuring that the PV activities for all Takeda development compounds and marketed products are conducted in compliance with regulatory requirements and industry standards: o Direct staff and systems responsible for monitoring the adherence to quality assurance programs, policies, processes, procedures and controls and ensure that all Takeda pharmacovigilance activities conducted in pharmacovigilance hubs and in LOCs are in compliance with Takeda policies, standards, and procedures and all applicable regulations. o Direct global PV inspection activities, including inspection preparation and inspection management, in close collaboration with R&D Quality Systems and Compliance. o Direct interactions with regulatory agencies related to GVP compliance issues. o Develop a close collaboration with Global Patient Safety Evaluation to drive performance improvement within Takeda, at Takeda’s suppliers, and at Takeda’s business partners.
Define and articulate the strategy for the overall philosophy, scope and key elements of oversight of GCP and GVP activities conducted in LOCs, in alignment and close collaboration with Commercial Quality, including but not limited to training, audits, vendor/CRO quality management, compliance oversight, and regulatory intelligence.
Ensure that progress through development phases in a compliant fashion such that compliance issues will not result in failure to approve.
Direct compliance consultation activities.
Ensure that the LOC audit program effectively identifies gaps and risks in the LOC’s quality management system for GCP- and GVP-regulated activities.
Create and maintain a quality culture of transparency and efficient communication of quality related matters to achieve and maintain the desired high state of quality: o On an ongoing basis understand, communicate, and mitigate compliance risk. o Establish escalation process for Global to ensure transparency and timely reporting of urgent/important issues. o Working with and internal and external partners, establish and monitor Quality goals and KPIs.
In collaboration with R&D Quality Systems and Compliance, progress and maintain the procedural documents that support GVP-regulated activities (across Takeda) and GCP-regulated activities (at the LOCs) including the development and maintenance of quality standards that are compliant with global regulatory requirements, aligned with Takeda and Global Quality requirements, and contemporary with industry trends and best practices. o Drive strategies for processes, standards, and systems that minimize compliance risk and operational inefficiencies and maximize a strategic level of standardization. o Promote quality and the compliance mindset of employees and management by communicating regulatory trends, regulatory compliance challenges, and strategies to identify and address gaps. o Ensure resources are adequate to fulfill quality and compliance strategies and goals. o Direct staff and systems that ensure timely and thorough completion of corrective and preventative action responses to audit findings, inspection commitments, and quality issues. o Direct staff tasked with interpreting evolving governmental regulations and agency guidelines and ensure standards and procedures assure complian*ce.
In collaboration with R&D Quality Services and Improvement, identify and communicate needs within supported functions for process improvement. Engage R&D Quality Services and Improvement to lead and support Operational Excellence initiatives such as Six Sigma and Kaizen events. *EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS: * Education & Experience * B.S. in Biology, Nursing, Pharmacy, or related scientific field. MS preferred.
Minimum 12 years of increasing responsibility in pharmaceutical,GCP- and/or GPvP related Quality environment.
Minimum 10 years of people and/or process management experience in GCP and/or GPvP Quality Assurance including senior level project planning/budget management.
Minimum 5 years of progressive matrix management experience, and extensive experience leading a team dispersed in multiple, global locations.
Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives
Skilled in managing global, cross-functional projects * Skills/
* * Regulatory Knowledge
- Expert knowledge of global GCP and GVP regulations and guidances; good working knowledge of global GMP and GLP regulations and guidances. Understands the regulatory environment for global pharmaceutical companies, as well as best practices in the Pharma industry to satisfy regulatory requirements.
Industry Knowledge – Strong working knowledge of the pharmaceutical industry and the new drug development process; understands the phases, processes and techniques used to execute a clinical development program.
Demonstrates advanced knowledge in the conduct and reporting of audits and investigations, as well as the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
In-depth understanding of the good practices for the creation and management of a Quality Management System.
- Possesses the necessary science education and knowledge to provide Quality Assurance oversight of clinical trials and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states.
- Communication Skills
- Must professionally, clearly, concisely and consistently communicate to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills.
- Negotiation Skills
- Demonstrates proficiency in negotiation and conflict resolution.
Personnel Management Knowledge – Proficient in managing large teams, and in providing coaching and mentoring to employees.
- Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
- Organizational Skills
- Must be able to prioritize work effectively to meet timelines, and delegate to subordinates.
- Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
- Computer skills
- Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members. LICENSES/CERTIFICATIONS: * ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional or equivalent preferred.
Six Sigma Green Belt or Black Belt preferred. *PHYSICAL DEMANDS:
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Carrying, handling and reaching for objects. *TRAVEL REQUIREMENTS:
Position is located in Boston.
Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel will be required.
Requires approximately 40 % travel WHAT TAKEDA CAN OFFER YOU: * 401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs Empowering Our People to Shine Learn more attakedajobs.com. Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspxNo Phone Calls or Recruiters Please.#LI-LC1
Job:Research and Development
Title:Head, Pharmacovigilance Quality Assurance and LOC Medical Quality Assurance
GCP Quality Assurance Auditor Iii/Principal Quality Assurance Auditor - Home-Based
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose- to improve health.
PPD's Clinical Quality Assurance department helps our clients ensure the integrity of their clinical trials. The Clinical Quality Assurance department advises clients on how to verify the integrity of scientific data and ensure adherence to protocols and international regulatory guidelines. A Quality Assurance Auditor III//Principal Quality Assurance Auditor conducts complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.
Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. Provides audit reports to management. Plans and delivers quality services for contracted quality assurance audits.
Essential Functions: Conducts and/or leads directed and routine GCP site audits and supports regulatory inspections as requested by senior management Leads directed site audits Provides GCP consultation and support to PPD project teams Serves as a resource and subject matter expert to operational departments on audit or quality assurance subject matter Provides support to internal teams on quality assurance questions and issues Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings Provides mentorship and guidance to junior auditors This position offers continued career advancement within the Clinical Quality Assurance team or into other clinical or operational roles within PPD. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. Key Words QA
- LI-JN1 Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years’) or equivalent combination of education, training, & experience. Knowledge, Skills and Abilities: Thorough knowledge of GCP and appropriate regional research regulations and guidelines Demonstrated proficiency and led a range of project based or internal GCP audits and vendor audits to high standards required by management Excellent oral and written communication skills Strong problem solving, risk assessment and impact analysis abilities Solid experience in root cause analysis Above average negotiation and conflict management skills Flexible and able to multi-task and prioritize competing demands/work load Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel Working Conditions and Environment: Work is performed in an office/ laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Physical
Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi -task. Regular and consistent attendance. Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law. *Job:Global Quality and ComplianceOrganization:Corporate-United States (CORUS)Title:GCP Quality Assurance Auditor III/Principal Quality Assurance Auditor - Home-BasedLocation:United StatesRequisition ID:142680Other Locations:North America
Quality Assurance Quality Control Inspector
What you will do: Provide inspection support and quality oversight for production maintenance. Perform inspections of aircraft and components to determine airworthiness and conformity. The areas of responsibility will include: Heavy, Component, Line Maintenance and some manufacturing. Must be certified under Part 65 and be willing to work under Parts 21, 91, 121, 125, 135 and 145. This position reports to Supervisor, Quality Control.
What you need: * Airframe and Powerplant License * 5 years experience in maintenance of large transport aircraft
Good interpersonal skills
Ability to write legibly
Preferred skills: * Documented Boeing 767, 757, 737, 727 and DC-9 & MD-80 training and heavy maintenance experience
Previous heavy maintenance inspection experience in Part 121 or 145 * Documented training and working knowledge of Non-Destructive testing in eddy current, ultrasonic, magnetic particle, penetrant and radiography
Documented training and working knowledge of geometrical dimensioning and tolerence (GD&T;) * Documented training and/or experience with Faro Arm with Polyworks software
Working knowledge of Parts 43, 145, 91 and 121
* AMES Level II Certified in Eddy Current Testing and two (2) of the following other NDT Methods: Ultrasound, Magnetic Particle, Penetrant, Radiography
Willing to provide OJT, guidance and leadership within the inspection group, including NDT as well as general QC tasks
Willing to travel as needed to support operational and customer needs
Willingness to fulfill all visual inspections and daily functions required of Inspectors without NDT qualifications
Excellent communication skills problem solving skills with all levels of the organization. AMES is an equal opportunity employer and that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status. Position: Quality Control Inspector
Employee Type:* Full Time
Leads Others:* No
Required Education:* Airframe and Powerplant License
Required Experience:* 5 years
Travel Required:* Occasional, short notice, up to 60 days
Quality Assurance & Quality Control (Qa/Qc) Director(Ami Program Management)(Job Id:Rfp-00391)
Quality Assurance & Quality Control (QA/QC) Director(AMI Program Management)(Job ID:RFP-00391)
Full-time Company Description Computer Consultants International, Inc. (CCI) is an IT Consulting Firm with more than 18 years experience providing effective, expert-level services in industries such as Construction, Technology, Finance, Healthcare, and Government. CCI focuses on building long-term relationships while completing projects from design to delivery. People are CCI's key component for success. Recruiting utmost-quality individuals for our clients, CCI fields a workforce of individuals who are selected not only because of their technical qualifications but also for their achievements as substantial, contributing human beings. In government work and in the commercial market, high standards of ethics and accountability are critical. Therefore our people are chosen for their integrity and ability to maintain relationships, as well as expertise in their field. To learn more about CCI, visit us online at www.cci-worldwide.com. Job Description The County is seeking a Candidate to provide program management and other services to oversee implementation of a complete, Turn-Key, AMI System inclusive of equipment, hardware, software, installation and services for Client’s, and full system integration services for the listed scope. The Candidate will work with the Client Quality Assurance & Quality Control (QA/QC) Director and executive team to provide program quality assurance and quality control (QA/QC) services, and to manage the scope, schedule, budget, and other issues related to this program. The Client us seeking an experienced Candidate with multiple areas of knowledge and experience with systems implementation, quality assurance and quality control, and change management to work in coordination with the Client program management team to provide program management, quality assurance, quality control, oversight and guidance for the entire program Qualifications
Candidate should have ten (10) years or more related experience managing quality assurance / quality control aspects of programs/projects similar in size, scope and complexity to this program.
Candidate should possess a current certification of one (1) of the following: Certified Quality Engineer, Certified Six Sigma Black Belt, Certified Quality Manager, and/or Certified Software Quality Engineer.
Candidate should have Experience in taking responsibility for overall quality assurance and quality control of the program.
Candidate should have Experience in auditing the entire program, including all parties and components as indicated in the program structure and organization chart developed for the program.
Candidate should have Experience in conducting program audits during each reporting period and is required to present a summary of a written report of audit findings and recommendations at the monthly Program Executive Management Committee meetings.
Candidate should have experience as the lead participant as a Quality Assurance & Quality Control (QA/QC) Director, installer or systems Implementer in at least one prior AMI System deployment
Candidate should have a successfully provided project management services or integration services for Oracle CC&B, Oracle MWM, and any Meter Data Management (MDM) system; and interfaced to billing/payment solutions, interfaced to Call Center and IVR solutions, and interfaced to a Website via web services.
Candidate should have a prior experience implementing CIS and/or AMI systems for municipal water and sewer utilities. Additional Information For immediate consideration, please send your resume to career(at)cci-worldwide.com with "Quality Assurance & Quality Control (QA/QC) Director(AMI Program Management)(Job ID:RFP-00391)FL" as the subject line. I'm interested
Quality Control/ Quality Assurance Inspector
Quality Control/ Quality Assurance Inspector
location:King Of Prussia, PA
salary:$17 - $17.50 per hour
date posted:Wednesday, February 14, 2018
-inspecting and testing materials for defects -overseeing production to ensure goals are met -cycle counting inventory -reporting findings to management -reporting in Microsoft Excel, must have intermediate level proficiency -Using calipers, micrometers etc Working hours: 8-4
-be able to interpret blueprints and drawings -use calipers and micrometers -be teachable -attention to detail effective communication skills -must be able to lift up to 50 Lbs -able to stand for entire length of shift -comfortable in team environment -positive attitude -must have high school diploma or GED at minimum If you are interested in this position or know someone who may be, please reply to this post or email your resume to Shannon at Shannon.Foley@randstadusa.com Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.
Quality Assurance / Quality Control Manager - Mortgages
Your role: The quality assurance (QA) / quality control (QC) Manager is responsible for overseeing and executing the QA and QC program for the Mortgage Product group. The QA/QC Manager will build relationships and interact with key control functions from across the firm such as: Compliance, Legal, Operational Risk and Internal Audit and will participate in special projects as needed. The QA/QC Manager will possess a strong understanding of and have experience with quality control, mortgage origination/underwriting and risk management. Principal responsibilities:
Direct and monitor the selection of mortgage loans for pre- and post-closing quality control reviews in conjunction with the external quality control vendor
Ensure all pre- and post-closing reviews are completed in a timely manner and in accordance with established UBS policies and procedures
Coordinate the review and remediation of all identified issues ensuring the appropriate root-cause analyses are completed and action plans are implemented timely
Provide guidance and assistance to quality control reviewers to determine the significance of any of the underwriting or collateral value issues and determine whether these items qualify as material defects that could result in a request for repurchase from any investors or have a direct impact to portfolio liquidity
Ensure the Quality Control Plan and Policies are up-to-date and meet all UBS, Agency and Investor requirements
Oversee and monitor external third party quality control firm(s) to ensure quality loan reviews, acceptable service level standards and monitor and manage costs
Ensure personnel have the requisite skills necessary to adequately perform their duties based on the results of QC reviews or test results by assisting management in developing training curriculum for personnel and recommending additions to the skills test to include making recommendations for personnel to determine additional training where needed
Implement policy and procedure improvements by working closely with the sales and operations teams, including the fulfillment vendors
Participate in risk management meetings and present topics pertaining to potential issues noted, industry trends or new investor guidelines
Review and analyze all investor Post Purchase Review reports for high risk trends and credit issues and recommend policy changes and/or training to offset accordingly
Evaluate and advise on third party services to manage loan risk and enhance productivity, including appraisal products, fraud detection, verification services and credit evaluation tools
Develop a deep understanding of the UBS mortgage business, the mortgage risk and control structure and assist the Mortgage Product and Risk Manager in developing a front-to-back risk and control strategy
Provide in-depth QA & QC reporting and analysis
What we offer: Together. That’s how we do things. We offer people around the world a supportive, challenging and diverse working environment. We value your passion and commitment, and reward your performance. Keen to achieve the work-life agility that you desire? We're open to discussing how this could work for you (and us). Video
Take the next step: Are you truly collaborative? Succeeding at UBS means respecting, understanding and trusting colleagues and clients. Challenging others and being challenged in return. Being passionate about what you do. Driving yourself forward, always wanting to do things the right way. Does that sound like you? Then you have the right stuff to join us. Apply now. Disclaimer / Policy Statements: UBS is an Equal Opportunity Employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skills and experiences within our workforce.
Your team: The Mortgage Product Group manages the residential mortgage offering for high net worth UBS clients and employees.
Your experience and skills: - University undergraduate degree
7+ years of experience in a residential mortgage environment (preferably the jumbo space) - 5+ years quality control, mortgage origination or other related experience which includes supervisory and/or quality control training experience
Strong understanding of the HNW/UHNW business or ability to learn quickly
Demonstrated strong Risk and Program Management skills with the ability to demonstrate a control mind-set
Proficiency in Microsoft Office (Excel, Word, PowerPoint, Project, Visio)
Ability to deliver quality results against fast-paced project deliverable deadlines
Experience writing policies, procedures and preparing audit/risk reports for senior management and for regulatory agencies as required
Ability to work very well with others as the role requires close coordination with all product, operations, sales, legal, compliance and support units, as well as external vendors and affiliates
Excellent written and oral communication skills
Strong organizational skills
Detail-oriented and careful about quality of work
Ability to produce professional-looking presentations and reports
About us: Expert advice. Wealth management. Investment banking. Asset management. Retail banking in Switzerland. And all the support functions. That's what we do. And we do it for private and institutional clients as well as corporations around the world. We are about 60,000 employees in all major financial centers, in almost 900 offices and more than 50 countries. Do you want to be one of us?
Your colleagues: Job Reference #:
166548BR Business Divisions:
Wealth Management Americas
Title: Quality Assurance / Quality Control Manager
Full Time Country / State: United States
- New Jersey
Function Category: Product Management and Development
Quality Assurance Technician / Quality Inspector - Day Shift
Rehrig Pacific Company is a family-owned, global leader in providing logistics solutions. We celebrate our people and empower them to create innovative solutions that effectively and responsibly move goods, resources and ideas.
At Rehrig Pacific, you’ll experience a family atmosphere that fosters learning and creativity and promotes your personal and professional growth. Our commitment to each other is what sets us apart from other organizations. You will have a chance to make an immediate, meaningful impact on the business.
As a Quality Assurance Technician, you will play a critical role in our organization by maintaining the quality excellence of our products and injection process while working safely with the production and management teams.
This role operates on a schedule of 12 hr/day for three days and 8hr/day for one day. The day shift hours are from 8:00am – 8:00pm.
We’re looking for individuals who value the same things we do: Family, Service, Growth, Intrapreneurship, and Innovation. If this is you, please consider joining our team!
As a QA Technician, you will:
- Follow all established safety and work standards and advocate safety throughout the plant. Safety is our number one priority.
- Complete First Part Approvals on every order to ensure work order accuracy against production.
- Measure and document part specifications several times a shift.
- Send Quality alerts for any deviations in part quality and place suspect product in need of rework on hold.
- Work with Processing, Tooling, Production, and Engineering on quality issues that arise until product is back to standard quality.
- Confirm cycle efficiencies against process change documentation.
- Validate the functionality of various components received from suppliers.
- Perform quality testing on incoming regrind/virgin material.
- Contribute to team effort by leading in-house product rework, job hazard analysis assessments for non-standard work, and 5S initiatives.
- Assist Quality Manager in completing quality improvement projects.
- Communicate with other Quality Techs between shift changes on recent quality issues and wins.
- Communicate regularly and effectively with production on quality issues and improvements.
- Allocate time towards self-improvement through training and team meetings.
- Manage process mold books for history tracking and consistency in machine processes.
- Perform quality training/audit to production staff.
- Consistently demonstrate Rehrig Pacific values in decisions and actions.
Qualifications for the role:
- High School diploma or GED preferred
- Ability to prioritize daily responsibilities
- Excellent communication skills
- Strong attention to detail
- Quality background/auditing is a plus
- Use of measuring instruments is a plus
- Knowledge of lean manufacturing is a plus
- Injection molding or manufacturing background is a plus
- Strong time management and organizational skills
- Experience conducting root cause analysis
- Ability to use Microsoft office programs like Excel (formulas and graphs)
Rehrig Pacific Company is an Affirmative Action/Equal Employment Opportunity Employer
Quality Control And Quality Assurance Specialist
Job Title: Quality Control and
Quality Assurance Specialist
Reports To: Quality Control Manager
· Responsible for ensuring all produced parts comply with customer’s specifications using tools such as calipers, gauges and using a coordinate measuring machine. Also, responsible for reviewing, improving and creating quality assurance policies and procedures.
- Performs first article inspections, in-process, and final inspections of materials and complex precision machined parts, including aerospace parts.
- Analyzes technical drawings to ensure compliance with customer or company specifications.
- Organizes and produces all required documentation for inspections and certifications for our customer and our records.
- Review current quality assurance policies and procedures, suggest and implement new or replacement quality assurance policies and procedures.
- Performs audits and checks on documentation for compliance.
- Calibrate equipment and monitor and maintain calibration logs.
- Properly documents and archives all quality control records.
- Collect, compile and analyze quality complaints and other non-conformance issues.
- Identify training needs and conduct training sessions.
- Assist others within the Quality Control team, to maximize efficiency and ensure optimum utilization.
- Communicates any delays or potential issues to supervisors as soon as they are likely. If needed and instructed to do so, may interact with customer to explain any NCRs or quality issues.
- Confer with engineering, supervisory, or manufacturing personnel to exchange technical information.
- Monitor ongoing regulations, standards and best practices in the industry.
- Maintains safe operations by adhering to safety procedures and regulations.
- Maintains continuity among work shifts by documenting and communicating action.
- Execute other reasonable duties as directed by supervisors.
- Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
- Acknowledge and follow company policies as laid out in the employee handbook.
- Required Experience: Knowledge and ability to independently document and perform quality control on parts using a Faro Arm (coordinate measuring machine); familiarity with inspection documentation
- Preferred Experience: 5+ years, or equivalent combination of education and experience in a tight-tolerance environment; experience with Microsoft Office; ISO 9000 experience
- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives.
- Operating – Uses conceptual and technical experience and skills to perform daily machining and set up activities; focuses on the job and exhibits a high attention to detail.
- Problem Solving- Identifies and resolves problems time efficiently; Gathers and analyzes information; Develops solutions; Works well in group problem solving situations; Uses reason.
- Oral Communication- Speaks clearly and persuasively; Listens and gets clarification when necessary; Responds informatively to questions.
- Written Communication- Writes clearly and concisely; Edits work; Varies writing style to meet specific needs; Presents numerical data effectively; Able to read and interpret written information.
- Required: Must be conversational in English. Preferred: Fluent in English, Spanish and/or Vietnamese.
- Required to able to bend, lift, climb, sit, stand and walk.
- Occasionally required to use hands to finger, handle, or feel.
- Occasionally required to reach with hands and arms.
- Occasionally required to talk or hear.
- Occasionally required to lift light weights (less than 75 pounds)
- Specific vision abilities required for this job include: close vision, distance vision, ability to adjust or focus
- Depending on the weather, climate controlled room.
Quality Assurance Manager - Sterility Assurance - Operations
The Quality Assurance Manager
Operations is located at BD UCC Division in Covington, GA. The Shared Services Manager, Quality Assurance – Covington Operations has the responsibility of managing the Covington Operations (Cov Ops) QA/QC functions. This includes the responsibility to maintain a department of well educated, trained, and motivated staff. This includes providing them with the tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional development for success. The primary functions are associated with Incoming Quality Control (e.g., Inspection Protocol, Re-inspections and Ship to Stock), Manufacturing (e.g., production, kitting, testing, rework), Materials Management, Labeling, and Hold, Release, Reject, Return to Vendor, Scrap, and Not for Human Use product disposition management.
Represents the Corporation, Division, Facility and Quality Department in a professional manner
Manages QC functions associated with Covington Operations activities (e.g., inspection, testing, production, kitting, rework, product release)
Member of CAPA Review Board for Cov Ops, providing oversight for Event/CAPA execution related to Cov Ops teams.
Manages non-conformance trends for the Cov Ops and provide oversight for corrections, trending, tracking, external communications, closure and reporting
Prepares and maintains department budgets
Hires, trains, develops, reviews and manages exempt and non-exempt employees (to include PMCP adherence and employee development deployment)
Provides management support in resolution of non-conformances
Prepares and implements facility policies and procedures relating to quality
Creates, reviews and approves Quality System documents (e.g., I/PS, IPs, quarantine, waivers, rework, validation)
Creates, reviews and approves protocols and summary reports
Analyzes process and product non-conformances and implements/manages comprehensive corrective and preventive action plans
Performs Internal Quality System and Supplier audits, as assigned
Ensures synergy and compliance to Corporate, Division, Facility and Department Procedures
Develops, tracks, trends, reports and maintains Quality Indicators to enhance quality of products and business performance
Participates in the implementation of Lean Manufacturing/Inspection/ Methodologies and 6-S Program activities
Manages QA/QC resources with respect to meeting Corporate-wide priorities to assure business continuity
Verbal communication skills and presentation skills: Ability to create and understands how to present information dependent upon the level of the audience.
Technical writing skills: Ability to create reports, rework protocols, validation protocols, metrics, reports, procedures, forms, flowcharts, quality plans, quality agreements, etc., and review and approve technical documentation, as required.
Management skills: Ability to prioritize resources based on changing business needs
Budgeting skills: Ability to control costs while providing appropriate resources in order to maintain compliance posture while meeting business needs.
Computer skills: Ability to create and manage technical documents, as needed; ability to use electronic communication, time management, ERP and EDMS systems.
Knowledge of medical device regulation, industry or international standards. Ability to understand Organization, Corporate, Division and other Facilities Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.
Knowledge and demonstrated use of Document Control, Training, Time Management, and Investigation (e.g., CAPA, non-conformance, thresholds, fishbone, 5-Whys) practices.
Ability to interpret Regulations, Organization, Corporate, Division, Facility and Department Procedures.
Comprehensive knowledge of quality systems and relationship to business.
Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
Broad knowledge of inspection, testing, product release, manufacturing processes and associated systems.
Fundamental knowledge of validation principles.
Understands basic applied statistics, statistical sampling plans, and statistical process control.
Ability to serve in leadership roles on projects or assignments.
Ability to identify opportunities for quality and cost improvements.
Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understand team functions, leadership techniques and project management methodologies.
Ability to effectively manage time.
Ability to handle multiple task assignments.
Ability to translate quality requirements into product specifications. LANGUAGE SKILLS Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedures/forms. Ability to effectively present information and respond to questions from groups of managers, peers and the general public. MATHEMATICAL SKILLS
College level mathematical skills (e.g., addition, subtraction, multiply, divide, fractions, percent, deviation).
Versed in statistics, modeling, optimization, data presentation and analysis and application to business problems.
Basic Applied Statistics, Statistical Sampling Plans, Statistical process control, DOE and Taguchi Methodology. REASONING ABILITY
This person will be working in a fast-paced, technically challenging environment where drive is critical to success.
Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person’s decisions could have a significant impact on health care practitioners and the welfare of their patients.
Highly variable operations performed daily, from complex regulatory and engineering decisions to routine administrative functions. This position involves reviewing and making decisions involving Personnel, Statistics, Document Control, Policy, Procedure, Specifications, Quality Acceptance, and Regulatory Compliance issues
The position involves making decision involving all areas mentioned above. In some instances, there are written policies or procedures that have to be interpreted. In some instances, only judgment based on past experience can be used. Judgment is critical to interpret a wide variety of quality requirements and documents. Critical to ensure only product available for release is release into commercial distribution.
Four (4) year Science, Engineering, Technology or Business Degree.
Five (5) years experience in a decision-making quality position with at least four (4) years in FDA/ISO/OSHA/etc. regulated industry (pharmaceutical / medical device).
Four (4) years management experience in a quality management role.
Thorough knowledge of regulations governing production, packaging, inspection (preferably incoming/final release), testing and warehousing. Employee may be required to sit, bend, stoop, climb stairs, use keyboard, see, talk and hear. May occasionally lift objects up to 30 lbs. May involve use of Personal Protective Equipment (PPE) or other safety equipment/requirements, as specified by facility/environmental conditions. On-call, overtime and/or weekend work may be required to support business needs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position generally works in a controlled office environment. Occasionally, the incumbent will be in hot and humid conditions, near moving mechanical parts, work in high precarious places, or have the potential to be exposed to toxic or caustic chemicals. Industry Standard/Category: Quality Assurance Manager/Quality ID: 2018-11092 Career Level: experienced Division Name: Bard Medical Division Relocation: Yes External Company Name: C.R. Bard, Inc. External Company URL: www.crbard.com C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.
Quality Assurance Quality Control (Qa-Qc) Technician
As a privately held family enterprise, Silent-Aire has been designing and manufacturing Custom HVAC and CRAC systems for over 20 years. We specialize in the Healthcare, Industrial and Data Center markets.
The Quality Control Technician is responsible for direct examination of product to ensure that quality standards and procedures are met and aligned with legislation and customer specifications. Requiring a high level of attention to detail, the Quality Control Technician is responsible for strictly adhering to the organization's quality assurance policies, and identifying defects and or production errors in order to prevent these materials from entering the supply chain. Other duties may be assigned as necessary.
Work schedule includes First shift M-Th 5a-330p Second shift M-Th 3:00p-1:30am Weekend/Part-time available also.
- Inspect production material as assigned for defects as trained.
- Remove defective items from production, designating reason for removal.
- Report defects to the appropriate manager.
- Perform internal QA audits that are compliant with corporate policies, practices, and procedures.
- Assist with the maintenance of QA monitoring programs, including audits, controls, and other qualifiers.
- Comply with Company QA programs for monitoring supplier quality, including audits, controls, and other qualifiers.
- Support new product development and continuous improvement and by integrating quality control tools (e.g. Lean, Six Sigma, etc.) into processes.
- Promote and advocate quality achievement and performance improvement across the organization.
- Ensure ongoing compliance with local, national, and international standards and legislation.
- Maintain QA control documentation
- This position requires shop work. When working in the shop, one must exercise caution as this environment presents many naturally-occurring and potentially worker-produced hazards including small or large projectiles, contamination with toxic gasses/liquids, impalement, crushing, electrocution, explosion, immolation, decapitation and asphyxiation. Safety policies must be adhered to at all times. Appropriate personal protective equipment (i.e. safety glasses, ear plugs, steel-toed boots, and others) must be worn at all times where required.
- It is very important that the incumbent of this position is able to work and communicate with prudence, while effectively managing time, completing tasks, and working safely.
- Able to occasionally lift items
- Overtime as required
Knowledge, Skills & Abilities
- Post Secondary Education in an appropriate field or a combination of education and experience.
- Knowledge of QA methodologies preferred.
- Practical experience with risk management, product testing, capability studies, and control plans.
- Training and knowledge of Six Sigma techniques and Lean Manufacturing are desirable.
- Set up training program for new inspectors.
- Highly motivated and self-directed capable of multi-tasking, and able to work with minimal supervision.
- Extremely detail-oriented and analytical thinker.
- Able to interface directly with cross-functional teams.
- Ability to manage change on the floor and work well with shift supervisors
- Ability to review technical documentation, including project plans, test procedures, and design documents.
- Able to develop, review, and maintain metrics and quality audits.
- Strong problem identification and problem resolution skills.
- High level of proficiency with Microsoft Office productivity suite preferred
- Strong work ethic and positive team attitude.
- Clear and concise communication ability
- Reports to: QA-QC Manager
- This is not an all-inclusive list. Other tasks may be added at any time.
Please visit our website to apply. https://www.silent-aire.com/careers/
At it's root Silent-Aire engineered and manufactured custom HVAC solutions for institutions; hospitals, schools, and recreational complexes. The company grew into larger industrial HVAC deployments for mining and energy companies. In early 2000 Dan and Lindsey graduated from University of Alberta with Civil and Mechanical Engineering degrees and took on the leadership and strategic direction of Silent-Aire. We continued to grow organically and acquired a new manufacturing facility in Edmonton that was the catalyst to expanding into the data center mission critical HVAC business.
In 2012 Silent-Aire built a second 100,000 square foot manufacturing facility in Edmonton that included 4 assembly lines and new office space for our engineering and operations. In 2014, for additional capacity and redundancy, a 3rd manufacturing facility was built in Phoenix, Arizona that mirrored the Edmonton facility. Today, we are focused on continuing to grow our industrial, institutional HVAC and mission critical data center business.
The majority of our growth over the past 10 years has come from our data center customers that require mission critical infrastructure for their ever expanding clouds. As a result, we have taken a relentless focus on operations, quality and safety that includes attaining ISO 9001 Quality, ISO 14001 Environment, OHSAS 18001- safety.
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