We are looking for a Senior Quality Compliance Specialist to join an amazing medical technology company based in Irvine, CA! This role will have a dedicated workspace and be onsite at least 80% of the time.
This contract position will ideal start in the moth of JAN/FEB of 2023 and run for 6 months with the possibility of an extension. The chosen candidate will be tasked with assessing complaint information. As well as, evaluating each event to determine whether it qualifies as a complaint, and escalating as needed.
Key responsibilities and requirements:
- Manage customer relationships and expectations during the course of complaint investigation and resolution process
- Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
- Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
- Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaints.
- Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required.
- Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
- Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing.
Education and Experience:
- Bachelor's Degree or equivalent in related field
- 5-7 years of experience required
Please apply with your most up-to-date resume to be considered.