Quality Compliance Specialist
The Quality Compliance Specialist is responsible for performing thorough investigations of product complaints in accordance with Company policy and external regulatory requirements, as applicable. The position also assists with Quality Management System reviews and quality audits.
- Facilitates the compliant handling process by receiving, reviewing and entering product complaint information into database.
- Coordinates and prioritizes complaint investigations to ensure that complaints are processed in a timely manner.
- Responds to client, regulators, or others as necessary within time restrictions.
- Organizes and facilitates meetings to discuss complaints, prepares meeting minutes, and follows up on action items.
- Evaluates information obtained during complaint investigation to determine if device failed to meet specifications.
- Resolves issues or provides clinical/technical explanation to complainant regarding reported event.
- Ensures proper disposition of returned products for complaint analysis
- Evaluates complaint information and determines appropriate regulatory reporting requirements. ·
- Prepare and submit reports to FDA and other regulatory agencies within required time frames.
- Prepares and analyzes complaint reports on a bi-weekly, monthly and annual basis.
- Participates in Post-Market Surveillance (PMS) activities.
- Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.
- Maintaining effectiveness when experiencing major changes in work responsibilities or environment (e.g., people, processes, structure, or culture); adjusting effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successful
- Having achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise; leveraging expert knowledge to accomplish results
- Ability to write and communicate in a professional manner
- Scientific/medical device background
- ISO Certification is a plus but not required
- Customer Service experience