Complaint Evaluation Supervisor Job Description Sample
Product Complaint Supervisor
The role of the Product Complaint Supervisor is to coordinate handling (i.e., receipt, evaluation, investigation documentation, filing and report generation) and the timely resolution of product complaints within the Huntington Facility including coordination with various departments, plant management, and Corporate Medical Safety (MS) as required to include Corrective and Prevention Action and Investigations.
Manage Team of Complaint Analysts - help complete complaint handling process, incl. generate & maintain procedures & documents. a. Build & develop team to understand & utilize new methods & technologies. b.
Engage & champion efforts to streamline complaint handling process; improve visibility & issue resolution. Conduct detailed investigations using inspection & laboratory equipment, record review & external data to determine if the complaint returns met product release specifications, to include identifying the root cause & implementing corrective & preventive action. Participate in Global Complaint Processing/Standardization activities representing the Huntington site.
Use software applications to build & maintain reports & assist in software development, troubleshooting & validations. Check complaint investigations/evaluations are complete. Occupational Demand
Position may require visual acuity, talking, reading comprehension, reasoning, calculating, composing, problem solving, verbally communicating, learning and retaining, presenting, negotiating, meeting deadlines, contact with external customers, irregular schedule, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Bachelor's degree or equivalent years of directly related experience English 3 years directly related experience
6 years of related experience/prefer some supervisory experience
Experience with business and regulatory requirements for obtaining information on product complaints and adverse events.
Strong analytical, reporting and communication (written and verbal) skills.
Must have a basic understanding of medical technology, anatomy of the eye, ocular disease terms. Maturity, judgment and tactful negotiations are required on a daily basis
Supervisor Complaint And Appeal
Responsible for the day-to-day management of staff to ensure effective resolution of member or provider/practitioner complaints/appeals. Responsible for organization and development of high performing teams to ensure timely, customer focused response to appeals.
Facilitates effective interfaces among team members, as well as, other business units. Responsible for day-to-day implementation of Aetna's complaints and appeals policies and procedures. Identifies trends involving non-clinical (CRT/PRT) or clinical (MRT) issues and reports on and recommends solutions. Accountable for meeting the financial, operational, and quality objectives of the unit.
Manages team's productivity and resources, communicates productivity expectations and balances workload to achieve customer satisfaction through prompt/accurate handling of customer concerns.
Manages a team of non-clinical personnel
Serves as a content model expert and mentor to team in regards to Aetna's policies and procedures, regulatory and accreditation requirements.
Manages to performance measures and standards for quality service and cost effectiveness and coaches team/individuals to take appropriate action.
Select staff using clearly defined requirements in terms of education, experience, technical and performance skills.
Build strong functional teams through formal training, diverse assignments, coaching, mentoring and other developmental techniques.
Assesses developmental needs and collaborates with others to identify and implement action plans that support the development of high performing teams and individuals.
Ensures work of team meets federal and state requirements and quality measures, with respect to letter content and turn around time for Appeals and Complaints handling.
Ensures all Complaints and Appeals units are utilizing the National tracking tool to ensure reporting consistency and trend analysis.
Holds individuals/team accountable for results; recognize/reward as appropriate.
Lead change efforts while managing transitions within a team.
Identifies trends involving non-clinical & clinical issues and reports on and recommends solutions.
Project management experience.
Experience documenting workflows and reengineering efforts.
ability to communicate clearly with auditors
The highest level of education desired for candidates in this position is a Bachelor's degree or equivalent experience.
- Desktop Tools/Microsoft Visio/1-3 Years/End User
- Desktop Tools/Microsoft Word/1-3 Years/End User
- Desktop Tools/Microsoft PowerPoint/1-3 Years/End User
Benefits Management/Interacting with Medical Professionals/ADVANCED
General Business/Communicating for Impact/ADVANCED
Service/Handling Service Challenges/ADVANCED
ADDITIONAL JOB INFORMATION
Aetna is about more than just doing a job. This is our opportunity to re-shape healthcare for America and across the globe.
We are developing solutions to improve the quality and affordability of healthcare. What we do will benefit generations to come.
We care about each other, our customers and our communities. We are inspired to make a difference, and we are committed to integrity and excellence.
Together we will empower people to live healthier lives.
Aetna is an equal opportunity & affirmative action employer. All qualified applicants will receive consideration for employment regardless of personal characteristics or status. We take affirmative action to recruit, select and develop women, people of color, veterans and individuals with disabilities.
We are a company built on excellence. We have a culture that values growth, achievement and diversity and a workplace where your voice can be heard.
Benefit eligibility may vary by position. Click here to review the benefits associated with this position.
Aetna takes our candidate's data privacy seriously. At no time will any Aetna recruiter or employee request any financial or personal information (Social Security Number, Credit card information for direct deposit, etc.) from you via e-mail.
Any requests for information will be discussed prior and will be conducted through a secure website provided by the recruiter. Should you be asked for such information, please notify us immediately.
Employment Type Regular Career Band Description Management
Inspection Support And Complaint Center Supervisor
Position Description Benefits Supplemental Questions
The Code Compliance Division of the Seattle Department of Construction and Inspections (SDCI) is seeking a well-qualified supervisor to lead the Inspection Support Analyst (ISA) team and the Housing Zoning Technicians who staff the Complaint Center. The ISA team manages complaints received from the Complaint Center that involve construction codes such as the building, electrical, sign, grading, and drainage codes, including issues arising from the environmentally critical areas code. The technicians team operates as the front door to the Code Compliance Division, receiving thousands of calls and emails each year and preparing complaints for investigation by enforcement staff. These teams work closely with the Code Compliance Inspectors, the Construction Inspectors, the Property Owner and Tenant Assistance group, and the administrative support team. This position is classified as "Housing Zoning Supervisor."
As a supervisor, you would join a team of four other supervisors who support Code Compliance staff as the Division works to improve the safety and livability of the built environment and the overall quality of life in our city neighborhoods. SDCI has a culture of learning and a tradition of providing excellent customer service. We take pride in our work and have fun doing it.
You will be successful in this position if you feel passionate about:
Protecting quality of life and improving safety and living conditions for the people of the City.
Being an active, positive, and contributing member on a team.
Working in the public sector with a community focus.
Maintaining a culture of service and fairness to all customers.
Collaborating across workgroups, divisions, departments, and with outside parties, on new program initiatives, individual cases and general policy and procedures.
Seeking opportunities to improve processes and data collection.
Your effectiveness in this role will depend on your ability to:
Supervise the work of your teams by
organizing, planning, prioritizing, and assigning work,
monitoring individual and group performance for productivity, timeliness, and quality of work, and
providing feedback and evaluation of performance.
Provide guidance to your teams on the application of City codes and policies.
Assist in the resolution of difficult, complex, or controversial cases or situations through good communication, problem solving, and diplomacy.
Ensure the timely and accurate collection of performance data, and prepare and present reports on performance to senior management and elected officials
Support the development and implementation of new programs such as the Renter-Landlord Assistance Center.
Oversee telephone and online communications with complainants.
Supervise research into permit records and property ownership.
Respond to inquiries from department management, other City departments, elected officials, and outside agencies, providing written documents or oral briefings as needed.
Assist staff in working with difficult customers including some that may be hostile, uncooperative, or antagonistic.
Maintain a comprehensive and up-to-date knowledge of the relevant codes.
Advise and assist in the development and revision of codes.
Understand and actively support the City and Department goals in promoting racial equity and social justice.
You will feel prepared to take on this role if you have experience in:
Communicating in person, by phone, and in writing to a broad range of customers, such as people filing complaints, property owners, tenants, building professionals, and attorneys.
Working in the public sector or in a regulatory role.
Multi-tasking and prioritizing work to meet deadlines.
Working with implementation of new technology (such as permit and complaint tracking system).
Developing and providing on-the-job training to new staff.
Evaluating staff performance and requiring or recommending corrective action when necessary.
These responsibilities are only a summary of typical functions of the job and are not intended to be an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties.
Requires five years of experience in code compliance, enforcement or dispute resolution in housing, land use, tenant protections, or a related field. Experience in the repair, construction, appraisal, inspection, or sale of residential and/or commercial buildings and property will be considered experience in code compliance.
The proven ability to supervise through one year of supervisory experience in a related field and/or a combination of education, training and experience that provides an equivalent background required to perform the work of the class.
Knowledge and experience with municipal development and housing codes
Experience working in a regulatory capacity
Experience working with diverse communities
Experience using workload or permit tracking systems to monitor and report on performance
Work Environment/ Physical Demands
This position works primarily indoors at the SDCI office but the following could be required:
Required to stand, walk, or bend for extended periods.
Required to work outdoors in all types of weather.
Required to inspect dilapidated and sometimes unsafe buildings.
Exposed to insects, rodents, unfriendly pets, and poisonous vegetation.
May require working around toxic/hazardous substances.
Includes contact with hostile and uncooperative persons.
The Seattle Department of Construction and Inspections is a proud participant in the Race and Social Justice Initiative, a citywide effort to realize the vision of racial equity.
We require a strong commitment to customer service and a demonstrated ability to work effectively with individuals from diverse communities and cultures. The City of Seattle values diverse perspectives and life experiences; people of color, women, LGBTQ, people with disabilities, and veterans are encouraged to apply.
Clinical Research Evaluation Supervisor - Military HIV Research Program
The Clinical Research Evaluation Unit Supervisor supports the Department of Laboratory Diagnostics and Monitoring for the Military HIV Research Program.
Manage, coordinate and execute clinical testing of sexually transmitted infections, blood borne infections and transfusion transmissible infections in support of clinical laboratory mission and research studies.
Oversight of US FDA Pre-Market Clinical Trials and other IRB approved clinical trials and non-clinical studies.
Support IRB submissions
Support development of Cooperative Research and Development Agreements (CRADAs) and Material Transfer Agreements (MTAs)
Provide support for internal, manufacturer (sponsor), CAP, and/or US FDA 483 regulatory audits
Serve as point of contact for manufacturer and sponsor study coordinators.
Provide regular project updates to Principal Investigators.
Master's degree in Health or Science related discipline
5 years of related experience including oversight of clinical trials.
Must be U.S Citizen / Must be able to obtain a National Security Clearance
As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.
Research And Evaluation Supervisor
THIS ANNOUNCEMENT IS OPEN TO CURRENT RESIDENTS OF COLORADO ONLY
Are you looking for a Job or a Meaningful Experience that will Challenge and Satisfy?
If your idea of success is making a difference in people's lives on a daily basis, we want you on our team! The professionals who represent the Colorado Department of Human Services work for the people of Colorado. Their work extends beyond the work space and touches the lives of families and individuals across our beautiful state.
About the Office of Children, Youth & Families and the Division of Child Welfare (DCW)
The Division of Child Welfare is a branch of the Office of Children, Youth & Families (OCYF), which consists of the Division of Youth Corrections, the Division of Child Welfare, and the Domestic Violence Program. OCYF is under the oversight of the Deputy Executive Director of Children, Youth and Families which reports directly to the Executive Director of the Department of Human Services.
This position is with the Division of Child Welfare (DCW). DCW provides a range of leadership, management and supervisory functions related to the delivery of public child welfare services to the children, youth and families of the state of Colorado. The Division provides administrative supervision for all child welfare programs in Colorado's 64 counties, and delivers technical support, monitoring, program improvement, regulatory oversight and other quality assurance functions.
Learn more about us here: https://sites.google.com/a/state.co.us/cdhs-dcw/
About the DCW Research & Data Unit
The DCW Research & Data Unit exists to provide data management and program evaluation through advanced analytical services that examine the policy context, planning and design, implementation, operation, outcomes, and costs of programs in Child Welfare, and uses these evaluations, where needed, to create business intelligence out of Child Welfare operational data for ongoing decision support. The unit develops automated systems that will create information essential to the effective management of the Division of Child Welfare Services.
The work unit also has responsibility for research and evaluation of child welfare services and performance outcome measurement in the Division of Child Welfare and is charged the management of data in formats that are useful to all potential users and acceptable to the federal government Adoption and Foster Care Analysis and Reporting System (AFCARS) and the National Child Abuse and Neglect Data.
Description of Job
In this role, you will be responsible for:
Serving as the Division's senior authority in statistical analysis and Child Welfare Research and Evaluation as related to best practices in child welfare, providing research and data analysis and reporting service for both internal Department of Human Services work units including, but not limited to: Performance Management Unit, Division of Youth corrections, Domestic Violence Program, and the Office of Early Childhood, as well as external agencies.
Serving as the State lead on all internal and contracted program evaluation efforts including evaluations required by state legislation and Federal grant requirements.
Serving as an authority on State and Federal evaluations of child welfare practice.
Collaborating with other Department of Human Services work units including, but not limited to: Performance Management Unit, Division of Youth corrections, Domestic Violence Program, and the Office of Early Childhood to ensure consistency around the development and tracking of Division of Child Welfare and Departmental outcomes.
Collaborating with County and other external stakeholders in the measurement and analysis of Child Welfare data and outcomes.
Your Responsibilities Broken Down by Percentages
25% - Research and Program Evaluation
30% - Data Collection, Data Analysis and Reporting
25% - Statistical Analysis
10% - Supervision
10% - Other Duties as Assigned
Minimum Qualifications, Substitutions, Conditions of Employment & Appeal Rights
Graduation from an accredited college or university with a Bachelor's degree Economics, Statistics, Mathematics, Psychology, Research and Methodology, Sociology, Public Health, Computer Science, Information management, Business, Public Administration or in a field of study related to the work assignment with minimum nine credits of statistics or data analysis classes
At least four year professional experience in independently designing and conducting research, state or federal policy impact analysis and statistical data analysis, program evaluation and outcome assessment, including analysis of large, complex relational databases, data extraction and manipulation using SQL or other similar database query languages, and statistical analysis using SPSS or other similar statistical software, state or federal policy impact analysis.
Definition of Professional Experience: Work that involves exercising discretion, analytical skill, judgment, and personal accountability, and responsibility for creating, developing, integrating, applying, and sharing an organized body of knowledge that characteristically is uniquely acquired through an intense education or training regimen at a recognized college or university; equivalent to the curriculum requirements for a bachelor's or higher degree with major study in or pertinent to the specialized field; and continuously studied to explore, extend, and use additional discoveries, interpretations, and application and to improve data, materials, equipment, applications and methods.
A combination of work experience in the occupational field or specialized subject area of the work assigned to the job, which provided the same kind, amount, and level of knowledge acquired in the required education, may be substituted on a year-for-year basis for the Bachelor's degree.
A Master's or Doctorate degree from an accredited college or university in a field of study related to the work assignment may be substituted for the Bachelor's degree and, at the agency's discretion, one or two years of the general experience respectively.
Applicants using education as a substitution MUST supply an unofficial transcripts before the application deadline to the Human Resources office. Applications requesting this substitution without transcripts will NOT be considered.
Master's or Doctorate degree in Economics, Statistics, Mathematics, Psychology, Research and Methodology, Sociology, Public Health, Computer Science, Information management, Business, Public Administration or other related field with minimum nine credits of statistics or data analysis classes
Five or more years professional experience conducting research, policy and statistical data analysis, program evaluation and outcome assessment
Two years of direct supervisory experience
Effective communication including advanced presentation skills using MS PowerPoint
Flexibility and adaptability to manage multiple priorities, assignments and tasks and adapt to changing priorities
Knowledge and expertise with research and data analysis methodologies
Proficient in SQL programming or other similar database query languages
Proficient in Statistical software such as SPSS, SAS, R, or other statistical software
Great analytic ability
Written and oral communication
Applicants are encouraged to attach a cover letter and resume to their application.
Please note that ONLY your State of Colorado job application will be reviewed during the initial screening process. If you submit a resume and cover letter, they will be reviewed in later stages of the selection process. Therefore, it is paramount that you clearly describe all of your relevant experience on the application itself. Applications left blank or marked "SEE RESUME" will not be considered.
Your application will be reviewed against the minimum qualifications for the position. If your application demonstrates that you meet the minimum qualifications, you will be invited to the comparative analysis process, which is described below.
Note: Current and former employees (transfers, voluntary demotions and reinstatements) are required to apply and participate in the comparative analysis process. Former employees of the Colorado Department of Human Services (CDHS) who were disciplinary terminated or resigned in lieu of termination must disclose the information on your application and may not be eligible for employment at CDHS.
Comparative Analysis Process:
The comparative analysis process for this position may consist of a Structured Application Review, Telephone Screening, Structured Interviews, Written Assessment, or a combination of these assessments. Candidates who most closely meet the job requirements will move through successive stages of the process. Applicants will be notified of their status via email following each stage.
If you receive notice that you have been eliminated from consideration for the position, you may protest the action by filing an appeal with the State Personnel Board/State Personnel Director within 10 days from the date you receive notice of the elimination.
Also, if you wish to challenge the selection and comparative analysis process, you may file an appeal with the State Personnel Board/State Personnel Director within 10 days from the receipt of notice or knowledge of the action you are challenging.
Refer to Chapters 4 and 8 of the State Personnel Board Rules and Personnel Director's Administrative Procedures, 4 CCR 801, for more information about the appeals process. The State Personnel Board Rules and Personnel Director's Administrative Procedures are available at www.colorado.gov/spb.
A standard appeal form is available at: www.colorado.gov/spb. If you appeal, your appeal must be submitted in writing on the official appeal form, signed by you or your representative, and received at the following address within 10 days of your receipt of notice or knowledge of the action: Colorado State Personnel Board/State Personnel Director, Attn: Appeals Processing, 1525 Sherman Street, 4th Floor, Denver, CO 80203. Fax: 303-866-5038. Phone: 303-866-3300. The ten-day deadline and these appeal procedures also apply to all charges of discrimination.
~THE STATE OF COLORADO IS AN EQUAL OPPORTUNITY EMPLOYER~
Product Evaluation Supervisor
?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.
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
- 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
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.
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world around us. Information about Agilent is available at
Roles and Responsibilities:
EU, FDA and ROW Complaint Investigation compliance, health hazard evaluation, medical device reporting, and post market surveillance of human, oncology and prenatal next generation sequencing products. Complaint investigation of assays involves microarrays, reagents, instruments, and software. Evaluate all incoming complaints (internal or external) to determine the level of investigation required and any reporting to regulated bodies and field. Trend and evaluate systemic issues and perform root cause analysis, corrective actions and preventive action (CAPA) for complaints, as necessary. Perform health hazard evaluation and risk assessment and determine and document for any recalls, field corrections and medical device reporting.
Develop effective testing parameters to understand the root cause of the complaint using input from the customer and internal SOPs. Maintain customer complaint documentation including complaint details, product return information as per the regulatory requirements. Communicate with marketing, R&D; and operations personnel during the course of the investigation of customer complaints.Manage interdepartmental/global teams to investigate and correct the root cause of all verified complaints through the established CAPA system. Record complete and accurate findings regarding each complaint investigation, including the conclusion and any corrective action required.
Communicate findings to technical services and management in concise summary formats. Determine the regulatory reporting requirements for each complaint and prepare the necessary reporting documentation for submission to regulatory agencies. These reports include Medical Device Reports, Vigilance Reports, Canadian Problem Reports, etc. Monitor MedWatch for any unreported claims and evaluate the need for an investigation. Track, compile, and report on complaint metrics.
Bachelors or Master’s degree in Biological Sciences or equivalent (BioInformatics, Chemistry or Bio-Chemistry is a plus)
3 years of laboratory bench work experience
Up to 5% travel may be required.
Familiarity with ISO 13485, ISO 17025 and QSR quality management system requirements and IVD products.
Proficient in Microarray testing, biological reagent testing, data analysis and workflow troubleshooting including instrumentation,
arrays and biological materials.
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
For more information about equal employment opportunity protections, please view the EEO is the Law’ poster available here:
Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1- (US and Canada only) or email . EOE AA M/F/Vet/Disability
- Date Posted:* 19/Mar/18
Job Title: Complaint Investigator
Business:* Diagnostics and Genomics Group
Job Category:* Quality/Regulatory
Job Sub-Category:* Quality
Country or Area:* United States
Town/City:* Santa Clara
Shift:* Day Job
Job Type:* Experienced
Travel Required:* Occasional
Duration (Temp Positions Only):* Not applicable
HR Country Location:* United States
HR Town/City Location:* Santa Clara
Product Complaint Specialist
Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization's potential and what we hope it will become.
Responsible for receiving, investigating, and responding to customer technical complaints including direct customer contact. Responsible for collecting data and preparing annual product reports. Provides detailed status reports and associated trending. Responsible for monthly metrics of complaints. Site liaison to Global Safety and Vigilance, and Customer Resource Center/Customer Service.
Receives and collects information on customer complaints from consumers. Communicates effectively with customers to obtain proper information. Responds to customers both verbally and in writing. Conveys a positive image of the company to customers.
Investigates complaints by coordinating laboratory testing and other investigatory methods. Gathers, examines, analyzes, and interprets information for investigation to determine proper conclusion. Perceives cause and effect relationships and considers all implications and outcomes; determines requirements for RC/CAPA issuance.
Prepares regular status reports for management to evaluate product quality trends and project status for Tampa complaints.
Site liaison to GSV, and CRC/CS.
Any other duties as assigned.
BS preferred (Natural Science area).
4+ years of pharmaceutical/FDA regulated facility or related field required.
Proficiency in computer operation
Ability to work independently and efficiently; good organizational and investigational skills; ability to follow detailed written procedures; able to handle multiple tasks simultaneously and prioritize accordingly;
Good communication skills, verbal and written; good analytical ability; ability to work well with others; good problem-solving skills; detail-oriented.
Be Aware of Recruiting Fraud
Valeant is an EEO/AA employer M/F/D/V.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
To learn more please read Valeant's Job Offer Fraud Statement.
Complaint Coordinator (589827)
The product coordinator supports the Sustaining Quality Engineering team domestically and internationally to ensure that complaints are processed in a uniform and timely manner. This position is responsible for ensuring that complaint investigations are thorough and are written with detailed, accurate statements.
Principal Duties and Responsibilities
Receive product complaints where Zimmer Biomet's product has failed to meet customer's expectations.
Accurately enter information from product experience reports into EtQ.
Decontaminate the returned product for further evaluation as needed.
Perform evaluation of customer complaints and complaint product in a timely manner.
Follow up with customers by phone or email to obtain all necessary information to effectively investigate each complaint.
Examine the device history record and other original source records as appropriate.
Gather sales data from the applicable computer systems to calculate occurrence rates.
Measure and inspect complaint product against product drawing, material, and production specifications.
Perform initial probable cause analysis and alert management to any nonconformance found.
Responsible for consistent decision making regarding MDR, MEDDEV, AUS, BRZ, CAN, JPN and CHN report ability.
Obtain Zimmer Biomet product knowledge through training and effectively discuss products and usage with internal/external customers as needed.
Create reports, charts, snapshots and dashboards in SharePoint, Excel and other reporting applications.
Support other key stakeholder departments in additional efforts required in the complaint resolution process.
Follow safety guidelines applicable to the area.
Perform related duties as required.
Expected Areas of Competence
Thoroughly familiar with Zimmer Biomet products and manufacturing methods.
Thoroughly familiar with product inspection methods and limitations of the inspection methods.
Able to perform basic dimensional and cosmetic inspection techniques on products, such as calipers, micrometers, etc.
Must be able to read and understand product drawings, work instructions, engineering specifications and inspection documents.
Must be able to communicate technical information, both verbal and written.
Must have demonstrated ability to use micrometers, calipers, scales and comparators.
Must have demonstrated ability to use shop math techniques (addition, subtraction, multiplication, division of decimals and fractions).
Must be able to work independently with minimal supervision.
Must have the ability to navigate through the applicable electronic systems for the retrieval of product specifications, inspection requirements, device history records, and complaint history records.
PC literate and demonstrate proficiency in Windows, word processing software, (Word, Excel), and other database applications.
Organized and effective work habits.
Associate's degree or equivalent experience/training is required
1 year of practical medical device manufacturing experience is preferred
Experience or knowledge in Quality Systems relating to 21 QSR Parts 803, 806, and 820 and ISO 13485:2003 is preferred
Less than 5%
Product Complaint Manager I Job
Date: Mar 12, 2018
Location: Marlborough, MA, US, 01752
Company: Boston Scientific
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work.
Product Complaint Manager I
About this role:
Responsible for the managing the Post Market Surveillance staff and all related compliance activities associated with complaint handling in both the Endoscopy and Urology/Pelvic Health divisions.
The scope of responsibility encompasses managing the complaint processes to comply with corporate procedures and applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, and ISO 13485:2003). Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards.
Your responsibilities include:
Ensures efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities.
Ensure departmental adherence to, and proper interpretation and complaint handling per the Code of Federal Register (CFR) and International Competent Authority regulations.
Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc.).
Monitors daily work operations as well as overall quality of processing, decision making, and reporting.
Works with the Manager II to identify key department objectives and metrics; implements strategies to meet them.
Leads development of operational policies and procedures within the Complaint Management Center. Works cross functionally to ensure optimal processes exist to support upstream and downstream customer needs.
Leads process and quality improvement initiatives.
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying disciplinary action as appropriate and conducting formal written and verbal performance reviews.
Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
Builds strategic partnerships to further departmental and organizational objectives.
What we're looking for in you:
Bachelor's degree plus 4+ years of related work experience or an equivalent combination of education and work experience.
Experience in medical device products and/or Post Market activities
Strong management and communication skills
Solid understanding of FDA 820/803 and ISO 13485 regulations
Strong analytical and problem solving skills, including the ability to identify and implement novel solutions to meet business needs
Ability to respond effectively and efficiently to changing demands
Demonstrated ability to motivate, lead, make decisions, and work in cross-functional teams
Strong organizational skills; can orchestrate multiple activities at once to accomplish goals as well as use resources effectively and efficiently
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 417893
Nearest Major Market: Boston
Job Segment: Gastroenterology, Medical, Law, Medical Technology, Manager, Healthcare, Legal, Management
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