Summary of Primary Responsibilities:
Coordinate, maintain and enhance the complaint handling program, including complaint trend analysis, returned product analysis and regulatory reporting (such as MDRs).
Position Description and Responsibilities:
- Develop, Coordinate and Maintain Complaint Handling Program and Adverse Event Reporting
- Receive, review and document complaint information timely and accurately.
- Verify the complaint information is completed thoroughly by Customer Service and determine if additional information is required to classify the complaint.
- Establish a complaint report file for each individual complaint, organize and maintain all complaint records and monitor all complaint records to ensure timely closure.
- Coordinate the process for complaint investigations and resolution, including returned goods evaluations, review of manufacturing records, decontamination, and inspection of samples, evaluations of raw materials, manufacturing processes and DHR review, and testing as appropriate.
- Maintain the complaint log timely and accurately to ensure inspection readiness at all times.
- Establish complaint metrics and generate trend analysis for monthly updates.
- Achieve technical and stylistic consistency between and among complaint documents to prevent contradicting information.
- Continually provide guidance to all employees for handling complaint information.
- Conduct returned product analysis investigations and DHR review. Document lab analysis results. Perform trending on complaint rates and provide feedback to the management team.
- Prepare initial and supplemental MDRs for regulatory reporting to the FDA in a timely manner. Ensure reporting of MDRs to FDA within 30 days.
- Actively communicate with external suppliers, regulatory agencies, distributors, Intuity departments and sales representatives to ensure timely closure of complaint files.
- Other Responsibilities
- Provide guidance, training and assist with the functions of the document control program as needed.
- Assist in FDA Establishment registration(s), FDA device listings, and California State Food and Drug Branch Manufacturing license.
- Assist with the corporate training program, Document Control or CAPA program activities as requested.
- Assist in preparing for Management Review presentations, handouts, and supporting documentation as requested.
- Assist in preparing for internal and external audits and inspections as needed
- Train and mentor other members of the QA team, as appropriate.
- Experience with FDA requirements, knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements. Proficiency in MS Word, Excel, PowerPoint and Access
- Excellent organizational skills and ability to work on several projects at the same time; high level of attention to detail skills
- Must be able to work independently in a fast-paced manufacturing environment
- Must be capable of prioritizing responsibilities and completing tasks on schedule and contribute positively in a team environment
- Must have initiative, motivation, good judgment, ability to manage multiple tasks with frequent interruptions, and high attention to detail and accuracy
- Strong work ethics
- Minimal travel (less than 10%) may be required to meet with the external Customer Service organization
- Minimum 5 to 10 years of experience working in complaint handling at a medical device organization.
- BS in Life Sciences or Engineering (preferred), or equivalent related experience and/or training in the medical device industry.