Job Description
1. Maintain and enhance the Quality Management System in alignment with ISO 13485 and FDA 21 CFR Part 820.
2. Serve as the point of contact for all FDA communications, audits, and regulatory interactions.
3. Establish Quality Agreements, manage supplier oversight, and ensure change control compliance for international manufacturing partners.
4. Lead post‑market surveillance including complaint handling, trend analysis, and adverse event reporting.
5. Conduct internal audits, support external audits, and drive continuous improvement initiatives.
6. Review and approve design documentation, risk assessments, design transfers, and change impacts on regulatory filings.
7. Oversee product release for distribution by reviewing batch records, test data, and supporting documentation.
8. Manage incoming inspection requirements, labeling compliance, UDI, and import regulatory obligations.
9. Lead non‑conformance investigations, root‑cause analysis, and CAPA programs.
10. Qualify and monitor suppliers through audits, scorecards, and performance reviews.
11. Provide training on quality system requirements and maintain up‑to‑date knowledge of evolving regulatory expectations.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
12. Experience with implantable medical devices is required - candidates without this background will not be considered.
13. 1-2+ years in Quality Engineering or Quality Systems within a regulated medical device environment.
14. Strong understanding of ISO 13485, FDA 21 CFR Part 820, risk management (ISO 14971), and purchasing/production controls.
15. Experience supporting FDA inspections, 483 responses, and audit remediation activities.
16. Skilled in root‑cause analysis, statistical analysis, CAPA management, and quality tools.
17. Excellent communication, documentation, and cross‑functional collaboration skills.
18. Highly detail‑oriented, organized, and capable of working independently in a global, fast‑paced environment.
19. CQE or related certification is a plus.
What's on Offer
20. Competitive annual salary ranging from $90000 to $110000 USD.
21. Opportunities for professional growth and development.
22. A supportive work environment within the Business Services industry.
23. Comprehensive benefits package.
If you are a results-driven Quality Engineer looking to make an impact, we encourage you to apply today!