Complaint Evaluation Supervisor Job Description Sample
Product Evaluation Supervisor
Our well-established and highly respected medical device client is seeking a Product Evaluation Supervisor to join their global operation. In this role, the hired candidate will ensure that the Product Evaluation Team is fully trained in all operating procedures. This person will also be responsible for validating the effectiveness of the procedures.
Key responsibilities include:
Supervise workflow and make adjustments via continuous improvement methodologies to ensure optimal accuracy, safety and productivity.
Timely and effective communication with all internal/external customers using established reports and forecasts.
Evaluate and coach individual members of the team's performance and adherence to company policies.
- Bachelor’s Degree or relevant experience required.
- 3-5 years supervisory experience, preferably in an equipment evaluation or warehouse environment.
- Knowledge of electro-mechanical medical devices preferred.
- Requires excellent verbal and written communication skills.
- SAP experience strongly preferred.
- Lean/continuous improvement experience/knowledge strongly preferred.
- Proficient in Microsoft Excel and Word required
- Ability to create a positive team environment
Please apply to Stephanie@moorestaffing.com.
Product Evaluation Supervisor
JOB SUMMARY ?The function of this position is to supervise laboratory operations performing testing of Product Evaluation. This position is responsible for application and evaluation of approved techniques and methodologies used in evaluation of food products.
The Product Evaluation Supervisor will have frequent contact with the client base as well as review, reporting and interpretation of results in collaboration with the management team. The Product Evaluation Supervisor will be responsible for overseeing of daily workload and staffing placement in the evaluation area while working closely with the Laboratory Manager and Assistant Laboratory Manager. ? ESSENTIAL RESPONSIBILITIES Interact with product evaluation clients and ensure satisfaction with excellent customer service and meeting turn around Coordinate product orders and pickups from distribution centers Create Certificates of Analysis and collecting critical data Complete data transfers and adhering to client specifications Complete tasks as assigned by management to include special projects or process improvement Participate and contribute in manager meetings to improve overall execution and efficiency of the product evaluations Develop, record, maintain and provide summaries of labor and supplies utilized to conduct the various product evaluations for each customer Serve as a resource for the team members Lead responsibilities include: Managing employee schedule Organizing workflow and processes Ensuring the team is consistently delivering on expectations and meeting quality requirements Acting as example to all team members to ensure a high level of confidence Facilitating team collaboration, problem solving, and customer communication Follow and direct team members in adherence to FSNS Quality programs including training records Independently pursue an assigned series of processes, procedures, or techniques in accordance with FSNS policies/procedures and customer requirements.
Maintain laboratory condition, to include equipment, supplies, quality assurance programs, and accurate records throughout all procedures Maintain a neat, safe, and hygienic test kitchen Perform all activities in a neat, safe, hygienic, and efficient manner Share information in an open and timely manner Responsible for the safety of oneself and others working within their area Responsible for the completion of required training ? Specific Duties and Authorizations Supervise all activities, including quality control records, forms, files, log, etc. ?Communicate directly with clients on laboratory results ?Ensure that the appropriate number of technicians are allocated are in the respective area of the Laboratory; this will include shifting people when necessary ?Submit staffing schedules to the Assistant Laboratory Manager and Laboratory Manager ?Oversee the scheduling of lunch breaks to ensure there is no down time in the laboratory ?Oversee status of all results and reporting for clients as needed ?Directly involved in the training of laboratory personnel and maintenance of training records ?Alert Assistant Laboratory Manager of need for repair services for malfunctioning?equipment Maintain visibility in all areas in order to be available to intervene where efficiency may be?lacking Directly address client needs as required and in collaboration with the Assistant Laboratory?manager and Laboratory Manager as required ? OTHER DUTIES Perform other duties as assigned ? Branch Safety Coordinator Duties (IF ASSIGNED): conduct all responsibilities outlined in the corporate safety manual and report to the Corporate Safety Officer for these duties ? SUPERVISORY RESPONSIBILITIES Directly supervises employees. Carries out all responsibilities in accordance with the organization's policies, standard operating procedures and best practices. Ensures compliance with all applicable laws and regulations at all times.
Responsibilities includes training and mentoring employees; evaluate performance of assigned personnel, monitor performance action plans for employees, may interview applicants, improve operational efficiencies by focusing on customer service and maximizing production and profit; will direct work flow; maintain harmony in the workplace and professional business demeanor at all times. SDL2017
Diagnostic Vocational Evaluation Supervisor (Crc)
Fedcap Rehabilitation Services, Inc. (Fedcap), a New York City-based not-for-profit human services agency, is contracted by the New York City Human Resources Administration to operate the Wellness, Comprehensive Assessment, Rehabilitation and Employment (WeCARE) Program in Brooklyn and Queens.
WeCARE is an internationally acclaimed workforce development program founded and administered by the New York City Human Resources Administration (HRA). WeCARE provides a continuum of integrated services designed to help public assistance recipients overcome barriers to employment and to become more financially self-sufficient. Program services include medical, mental health and substance abuse assessments and referrals; case management; comprehensive service planning; vocational evaluations; federal disability program application preparation and submission; work readiness and computer skills training; academic and vocational education referrals; work experience internship placement and monitoring; and job placement and retention services.
Reporting to the Assistant Director, Vocational Rehabilitation Services, the DVE Supervisor manages and supervises the Vocational Evaluation team and assesses the work skills, abilities, work readiness, and vocational potential through administration of aptitude and educational achievement of the clients at the program site.
* Researches, develops and implements new tests, measure and report formats to meet the needs of the agency and varying disability populations
* Mentors, coaches and assists in the training of other staff members as necessary.
* Supervise the measurement and recording of client responses to motivational technique and criticism, as well as organizational ability, perseverance, attendance, punctuality, flexibility, interpersonal skills, work habits and communication skills.
* Oversee the development of employment plans, including education and vocational training referrals, Work Experience Program (WEP) referrals, and appropriate jobs/job families, based on the results of the DVE and other medical, mental health, substance abuse and psychosocial assessments.
* Case conference with other WeCARE service providers on an as needed basis, including case managers, work readiness and computer instructors, job placement coordinators, job preparation counselors and WEP specialists.
* Other duties as assigned.
* Bachelor's degree in vocational rehabilitation, vocational education, psychology, or
education or the equivalent in a related field.
* Current Certified Rehabilitation Counselor credentials from the Commission on Certified
Rehabilitation Counselor Certification
* Minimum of 3 years prior relevant experience in vocational assessment required with 1 year
in a Supervisory role.
* Knowledge of vocational systems and valid testing procedures required as well as
knowledge of the labor market and world of work.
* Highly organized and detail-oriented.
* Ability to be patient and sensitive to individuals with disabilities.
* Excellent oral, written and interpersonal communication skills.
* Must be computer literate with a working knowledge of MS Word and MS Excel.
* Bi-lingual (English-Spanish) candidates preferred.
Each year, Fedcap offers an array of services through its four practice areas Education, Workforce Development, Occupational Health, and Economic Development helping more than 100,000 individuals graduate from high school, obtain vocational certification or a college degree, become work ready, obtain meaningful employment and achieve economic well-being.
Complaint Resolution - Regulatory Coordinator 2
Let’s talk about building a rewarding career* You’ve got the passion. You’ve got the skills. Now you just need the right opportunity. At Wells Fargo, you’ll have the chance to join a team of smart and talented people who share the same values. Our diverse lines of business offer a world of opportunity to expand your capabilities and advance your career. We invest in our people and provide a supportive environment in which to learn and grow. Wells Fargo & Company (NYSE: WFC) is a nationwide, diversified financial services company with $1.7 trillion in assets. Founded in 1852, Wells Fargo provides banking, insurance, investments, mortgage, and consumer and commercial finance through more than 9,000 locations, more than 12,500 ATMs, online (wellsfargo.com), and mobile devices. Wells Fargo has more than 265,000 team members in 36 countries across our approximately 90 businesses. The Law Department has seven divisions that support Wells Fargo products and services. We support the vision and values of Wells Fargo by giving expert, creative and timely advice to all Wells Fargo businesses and support functions. The Law Department strives to offer services in accordance with the highest standards of judgment, integrity and ethical leadership.
- Job Description* This position will provide support to the Law Department’s Wealth Investment Management Legal Regulatory Team. The role requires a self-starter who can successfully manage multiple areas of responsibility and deadlines within the Division, including evaluating requests from regulators, understanding the key issues and attendant risks in light of the securities, insurance and other laws and regulations and working independently to respond in writing and answer questions during discussions with regulators. The successful candidate will partner with attorneys where appropriate and will provide support to a very specialized team within the Law Department, requiring the ability to work on complex legal and regulatory issues and analyze key risks in a matter, communicate with senior leadership, direct the work of paralegals and work on cross functional teams in analyzing complex data and designing policy and operational solutions to ensure the firm is compliant with securities and other laws and regulations. This role requires someone with the ability to multi-task in a deadline driven environment.
* 3+ years of experience handling client service complaints within a broker dealer environment or 3+ years of legal experience including; the review, evaluation and response to agency, bank, brokerage or regulatory inquiries
Extensive knowledge and understanding of applicable laws, regulations, and guidelines related to one or more of the following: employment laws, securities products, and legal securities issues
Basic Microsoft Office (Word, Excel, and Outlook) skills
Strong analytical skills including analyzing complex data
Extensive math skills
Excellent verbal, written, and interpersonal communication skills
Ability to articulate complex concepts in a clear manner
Independent negotiating, conflict management, and decision making skills with ability to deal with all levels of the organization
Outstanding negotiating skills
Advanced level diagnostic skills
Ability to draft assessments of complex issues for business partners and senior management
Ability to comprehend and articulate trends in assigned cases and regulatory/legal schemes governing the industry
Ability to develop and manage business relationships
Strong time management skills and ability to meet deadlines
Ability to work independently
Ability to organize and manage multiple priorities
Strong organizational, multi-tasking, and prioritizing skills
Ability to research, trend, and analyze data How to Express Interest in This Job: Wells Fargo invites you to apply for this job at https://employment.wellsfargo.com/psp/PSEA/APPLICANT_NW/HRMS/c/HRS_HRAM.HRS_APP_SCHJOB.GBL?Page=HRS_APP_JBPST&FOCUS=Applicant&SiteId=1&JobOpeningId=5382014&PostingSeq=1. All offers for employment with Wells Fargo are contingent upon the candidate having successfully completed a criminal background check. Wells Fargo will consider qualified candidates with criminal histories in a manner consistent with the requirements of applicable local, state and Federal law, including Section 19 of the Federal Deposit Insurance Act. Relevant military experience is considered for veterans and transitioning service men and women. Wells Fargo is an Affirmative Action and Equal Opportunity Employer, Minority/Female/Disabled/Veteran/Gender Identity/Sexual Orientation. Relevant military experience is considered for veterans and transitioning service men and women. Wells Fargo is an Affirmative Action and Equal Opportunity Employer, Minority/Female/Disabled/Veteran/Gender Identity/Sexual Orientation.
QA Complaint Specialist
Title: Medical Complaint Specialist
Job ID: 18-00428
Austin, TX 78753
Duration: 6 months
Contract Type: Hourly Contract Position (w2 only)
Under direct supervision, provides support to the department supervisor as a team leader and subject matter expert in a variety of complex duties associated with managing product complaints and supporting patients/customers associated with Client pharmaceutical, biologics, and combination products.
The Quality Specialist III will initiate, own, processes, maintain, and conclude complaint files including determination of the appropriate investigation team based on manufacturing/packaging site and complaint type and nature.
Results of the investigation will be incorporated into the complaint record and the Quality Specialist III will determine the appropriate root cause, conclusion, and action plan based on the investigative findings.
This includes facilitation of product replacement and reimbursement as needed.
Additionally, the Quality Specialist III will assist in monitoring intake and processing workloads and timelines.
Key Duties and Responsibilities
Initiate, evaluate, assess and maintain complaint files, following complaint handling internal procedures. Analyze information obtained and create children records to be assigned to the site of manufacture/packager.
Critically think how the reported event is best processed and investigated based on the global Client structure.
Initiate and set up child records. Maintain and update Global TrackWise database. Record all complaint activity in both hard copy (when applicable) and TrackWise records.
Assess incoming documentation from intake group and ascertain compliance to product specification and/or intended use as indicated in the product labeling. Adverse event and off label usage complaints are to be reported to Pharmacovigilance. Combination events, such as Lack of Effectiveness, will be shared with both Product Quality and Pharmacovigilance.
Expedite shipments for Complaint Sample Retrieval. Maintain oversight on location of complaint sample to provide status to sites as requested.
Solicit investigation status updates directly from site of manufacture/packager and evaluate analysis results on all submitted records.
Collaborate with manufacturing sites, packaging sites, third party quality, and corporate quality to make and document appropriate regulatory decisions.
Advise site to initiate further complaint investigations, and provide any additional follow-up and communication pertinent to the product complaint as needed.
Track and control files sent to site of manufacture/packager for investigation and complete necessary documentation and monitor timelines.
Evaluate Complaint Investigation results, and close records when all requirements are met.
Maintain a knowledge and understanding of current product labeling, other federal laws governing pharmaceutical complaints, Department of Transportation (DOT) requirements for complaint sample returns, and other global regulatory requirements as needed.
Process, evaluate and maintained files for reconciliation reports with various departments.
Act as a Subject Matter Expert in department responsibilities and act as a team leader as needed. This includes:
Team oversight and guidance.
Monitoring of daily activities and team performance.
Monitoring of workload distribution, processing timelines, procedural/regulatory compliance, and overall record quality.
Support of global complaint processing as needed.
Collaboration with global Client colleagues.
Backup and delegate for the department supervisor.
Develop, implement, and lead company, departmental and product knowledge as required:
Communicate and provide critical feedback and direction to a variety of departments such as Quality Assurance, Customer Relations, Operations, Marketing, Medical Information, Global Safety and Epidemiology departments, and Client /Third Party manufacturing/Packaging facilities, Physicians, Pharmacies, etc.
Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues, providing information, education and assurance to the patient and/or physician regarding product and service, effectively utilizing "talking points and communicating corporate policy.
Support and monitor department product reimbursement.
Ensure team is applying product reimbursement based on procedural and business guidelines
Inform internal and external customers of Client reimbursement policy and product return requirements.
Ability to monitor several cases at once, including status and follow-up as necessary.
Respond to verbal and written requests from internal and external customers for compensation of product quality complaints and adverse events.
Ability to identify potentially litigious customers, and forward to management for resolution.
Identify, initiate, and lead projects within the department.
Projects may include:
Lead special projects as directed by department leadership
Write/revise department procedures as assigned.
Train new staff and conduct training/re-training on company policies, and departmental practices.
Assist in performing complaint audits.
Provide project and team leadership as needed.
Participate in Regulatory Inspections and potentially directly interact with auditors during regulatory inspections. Education and Experience
Bachelor's degree, with three to five years of previous experience in Quality, Regulatory, Clinical, and/or Customer Management (in a regulated environment) setting; or equivalent combination of education and experience.
Previous leadership experience is preferred. Essential Skills and Abilities
Ability to act as a Subject Matter Expert in complaint management and customer interactions.
Ability to act as team leader associated with various department activities.
Ability to problem solve through vague and unclear information.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, medical reports, and legal documents.
Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
Ability to use word processing, spreadsheet, and database applications. Ability to learn various and multiple software programs.
Ability to handle confidential data in accordance with HIPAA and related international standards.
Ability to function in a controlled environment regulated by the FDA and other regulatory authorities. This encompasses knowledge of current regulatory requirements, guidelines, and interpretations. It also includes potential regulatory inspections participation.
The specific requirements include, but may not be limited to:
ISO 13485:2016 and ISO 14971
FDA's 21 CFR Part 211 and Part 314 (Drug Product Regulation), Part 600 and 606 (Biologics Product Regulation), 820 (Quality System Regulation), 803 (MDR Regulation), and Part 4 (Combination Product Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures)
Global regulatory requirements as needed
Knowledge of clinical, surgical techniques and procedures, and medical terminology.
Skill in demonstrating a professional phone manner.
Effective communication with physicians and nurses as required.
Expertise in complaint policies and requirements.
Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
This includes communication with pharmaceutical, biologic, device, and combination product quality and regulatory business professionals both internally in Client and externally in the industry.
Ability to advance learning about Client Pharmaceutical, Biologics, and Combination products and procedures/techniques associated with their use.
Ability to take initiative and make decisions.
Ability to develop and deliver department guidance and training content.
Ability to demonstrate leadership in job performance by example.
Ability to accurately perform detail-oriented work.
Ability to be flexible in changing daily workload priorities as directed.
Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
Ability to lead, coordinate and synchronize multiple projects.
Ability to think critically and analytically to evaluate each record on a case-by-case basis.
Ability to provide team members guidance and appropriate decision making to ensure regulatory compliance, adherence to our policies/procedures, and meeting business needs. Must Have
Madhusoodana / Recruiter
Sunrise Systems Inc.
105 Fieldcrest Ave Suite# 504, Edison, NJ 08837 USA
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Sunrise Systems Inc.
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Sr. Quality Engineer - Field Assurance Complaint Lab
The Sr. Quality Engineer - Field Assurance Complaint Lab position is located at C. R. Bard Medical Division in Covington, GA. This position is responsible for working in the Bard Complaint Laboratory to perform product testing as well as planning, organizing, and tracking work activities. Quality results are expected to ensure the integrity of Bard complaint investigations. Additionally, the Quality Engineer functions as a subject-matter resource for Engineering, Operations, Sterilization and outside suppliers.
Represents the Corporation, Division and Quality Department in a professional manner.
Provides support to Project Teams and Quality Department.
Responsible for all products testing in the Complaint Laboratory.
Creates investigation files in the BARD Global complaint system (Trackwise).
Performs complaint investigations for all BMD and OEM manufactured products
Manages completion of assigned complaint investigation files and works with the manufacturing site, where necessary, to complete the investigation within a timely fashion.
Creates, reviews and approves Quality System Documents (CAPA, Audits, SPAs and R002s)
Creates, reviews and approves SOP Documents.
Sets up, safely operates, and maintains laboratory equipment and testing instruments.
Performs tests and experiments in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Develops and maintains a working knowledge of BMD policies and procedures and ISO and FDA requirements.
Maintains accurate data, analyzes and summarizes conclusions drawn from investigation and product analysis .
Performs tasks accurately and with great attention to detail.
Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by Bard policies
Ensures compliance to Department and Division procedures.
Interfaces with manufacturing facilities, suppliers, and PLM groups.
May present data findings to peers, engineering and management staff.
Technical competence in testing and writing and responsible for timely notifications based on new information received to FA specialists to meet FDA reporting requirements. •
Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems.
Basic knowledge of medical device regulation, industry or international standard.
Broad knowledge of Medical Device complaint reporting requirements.
Good laboratory skills, along with a working knowledge of laboratory bench methods and associated equipment.
Understanding of laboratory instrumentation.
Good understanding of OSHA requirements, Quality Systems Regulations (QSR), Good Laboratory Practices (GLP), ISO, AAMI, and FDA Guidelines, as well as any other regulations/requirements as they pertain to the laboratory.
Broad knowledge of manufacturing processes.
Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
Understands Fundamentals of Engineering Principles.
Ability to effectively manage time and manage priorities to meet deadlines.
Ability to handle multiple task assignments.
Ability to interpret Corporate, Division and Department Procedures.
Ability to work with minimal supervision.
Ability to work in a team. LANGUAGE SKILLS Ability to read, analyze, and interpret general technical procedures or government regulations. Ability to write simple reports and business correspondence. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. REASONING ABILITY
This position requires good judgment. All product and process development are to be carried out according to the applicable laws and regulations. When in doubt, the incumbent should source out the appropriate information via internal and external resources.
Highly variable operations performed daily from complex regulatory and engineering decisions to routine administrative functions. Interpretation of regulations (GMP, ISO 13485, EN46001) into standards and procedures as required. The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary.
A great deal of work must be initiated through a detailed knowledge and understanding of the job function, the establishment of plans to attain the end goal. There is a great deal of freedom of action, originality and imaginative drive and critical analysis since there is not strict day-to-day supervision. The success of implementation of quality plans is largely dependent upon the person’s ability to recognize the most efficient, cost-effective approach to attaining the desired goal. In many instances, the person will be required to use creativity and imagination in carrying out the job function. 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.
Prior laboratory experience desirable
S. in Engineering, Engineering Technology, Science a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
Experience with Access Databases, Excel (PIVOT Tables and Charts) and complaint handling software (Trackwise or Pilgram)
Sr. Quality Engineer
Minimum 7 years of experience with regulated industry, including co-op/internship experience and 2 years in quality function. Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. his position works in a normal office environment. The noise level in the work environment is quiet to moderate. Frequent travel is required. When traveling to clinical sites or hospitals, the work environment will be specific to the area under evaluation. Industry Standard/Category: Sr. Quality Engineer/Quality ID: 2017-10979 Career Level: experienced 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.
The Complaints Analyst will be responsible for maintaining the quality processes associated with regulatory reporting and its procedures and controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards.
- Responsible for the complaints regulatory reporting process (timely submissions, closure, health authority requests etc.)
- Evaluates all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
- Escalate critical issues for proper disposition as necessary.
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies.
- Ensuring personal and company compliance with all Federal, State, local and company regulations.
- Support Product Analysis Evaluation if required.
Headquartered in Tampa, FL, with operations in all 5 regions, The Fountain Group is a Contingent Labor Resource Provider. The Fountain Group services clients directly, clients with an internal contingent labor program, and clients with an external managed service program.
At The Fountain Group, we know that searching for a new career can be stressful, which is why we take time to understand your skills and personal goals. We understand the importance of job flexibility and professional growth, and offer top-notch positions with leading employers. In fact, the majority of our clients are well known Fortune 100-500 companies. We also offer a variety of benefits to our associates to ensure their overall happiness.
In addition to assisting with your job search, we will help you through every step of the process offering online tutorials and additional resources to enhance your industry knowledge and skills. As your employment agent, we are dedicated to providing career counseling and job advice, knowing precisely what established companies want.
At The Fountain Group, we treat you like family, regardless of your proximity to our office. We are dedicated to providing you with an exciting, challenging and highly rewarding place to work. Become a part of our team today and let us put your talents to work.
If you are interested in hearing more about the position please respond to this email with a copy of your resume in word form with the best contact info Please forward this email to any friends or colleagues
Sr. Manager, Complaint Management
Sr. Manager, Complaint Management Ascensia Diabetes Care16 reviews-Tarrytown, NY Job Summary Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes. POSITION PURPOSE:Ascensia Diabetes Care has an opportunity within our Quality organization to manage and lead the Quality Complaint Management group, which includes complaint evaluation, failure analysis, customer product support, pre-launch product training, product quality and safety processes, and worldwide metrics analysis. This position will continuously improve existing processes and introduce new approaches and new technologies. A primary focus is to resolve issues which are highly complex and require very knowledgeable and sophisticated statistical and scientific approaches for effective resolution. This position demands the ability to work effectively within technical groups involving many different disciplines. MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
Manage ongoing technical support including investigation of customer complaints, returned goods testing and product problems.
Report product performance problems and product use trends.
Resolve product problems, provide timely feedback of resolution to customers, and ensure that appropriate corrective actions are implemented to address the root cause.
Work cross-functionally with Quality, Regulatory Affairs, Product Supply, Medical, Legal, Global Strategy, and Customer Service to analyze and resolve complaints.
Collect, analyze and monitor world-wide quality metrics for system improvements.
Develop short and long-term budget plans.
Work directly with the quality and service organizations globally to provide compliance training for complaint management and provide pre-launch training as needed.
Coordinate the execution of Stop Shipments when required.
Coordinate the Product Quality and Safety Process, including Issue Analysis and Health Risk Assessments. QUALIFICATIONS:
Graduate Degree in one of the life sciences or an engineering discipline, or equivalent in experience and training.
Ten (10) years of experience in Quality Assurance or a related field. At least five (5) years of experience in the management of a scientific discipline.
Must have familiarity with Quality System requirements in relation to compliance with the international medical device regulations identified in GSOP99-01, Diabetes Care Quality System Manual.
Excellent analytical skills and judgment.
Good understanding of statistical techniques.
Broad understanding of Good Laboratory and Good Manufacturing Practices, appropriate Diabetes Care policies, and various government regulations.
Strong organization, communication, leadership, and management skills to direct diverse, multi-disciplinary functions, prepare and manage budgets, and select, train, and motivate a qualified staff.
Ability to interface with people from different cultures, with varying levels of proficiency in a common language. YOUR APPLICATION:Ascensia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice. TO ALL RECRUITMENT AGENCIES:Ascensia does not accept unsolicited third party resumes. Ascensia is an Equal Opportunity Employer. IND123 Job Type: Full-time
Sr Quality Assurance Scientist - Complaint Handling
Danaher Company Description Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Description The Senior Quality Assurance Scientist on the Post Market team will participate in complaint handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience.
* Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by the company in a manner consistent with all laws and regulations for medical devices.
Generate and analyze customer feedback (CF) data to improve product reliability and performance for our customers.
Assess complaint information for determination of adverse event reporting and/or vigilance reporting.
Possess understanding of risk management concepts and is capable of assessing product risks across unit of work.
Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action, and/or Stop Shipment activities.
Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements.
Oversight of critical Post Market projects and routinely share project goals, status, requirements, and deliverables to upper management. Communicate, work cross-functionally and consult frequently with Manufacturing, Operations, Engineering, Service/Support, Sales, Research and Development, Quality, Regulatory and Marketing. Ensure completion of key deliverables.
Bachelor’s degree with 5 years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
Master’s degree with 3 years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
Medical Technologist /Clinical Laboratory background preferred Experience desired:
Knowledge of domestic and international quality systems and other standards such as FDA, QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations.
Ability to drive results, foster teamwork, handle pressure, and provide feedback
Experience leading cross functional teams 1.
Danaher Corporation Overview Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Beckman Coulter - Diagnostics
Quality and Regulatory Affairs
Primary Location: North America-North America-United States-FL-Miami
Req ID: BEC008663
QA Complaint Admin
PDS TECH INC. is seeking QA Complaint Admin position located in Salt Lake City, UT
The QA Complaint Admin will be responsible for assisting with processing of complaint records through Master Control.
Must be people friendly and able to take direction. Must be computer literate and able to learn new software quickly.
Must be able to think logically and make decisions, but also be willing to ask questions when unclear on how to process a complaint record.
Analytical experience desired. Good computer experience (Word, Excel, Windows) is a must.
• Reviewing complaints for report-ability to regulatory bodies • Assist in submission of MDR's to FDA for reportable events
• Self-starter and able to manage a variety of tasks simultaneously with minimal day-to-day work instruction • Excellent analytical and communication skills • The ability to work well under pressure • Ability to effectively communicate via email/telephone • Strong computer skills including Word, PowerPoint and Excel • Able to succeed in highly regulated compliance oriented environment while still providing service excellence • Experience as an Administrative Assistant a plus • Experience in a Customer Call Center Environment a plus All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
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