Job Description
Key Responsibilities as Sr. Quality Engineer:
1. Ensure product quality, safety, and effectiveness through thorough investigations and quality oversight.
2. Guide project teams in applying quality systems, regulatory standards, and industry best practices.
3. Partner with engineering to develop and refine documentation supporting design controls.
4. Lead or support validation protocols and perform design risk assessments with clear mitigation plans.
5. Oversee CAPA, change control, audits, product release processes, and quality documentation management.
6. Coordinate Design History File and Device Master Record creation for clinical and scale‑up builds.
7. Communicate effectively with customers and suppliers, including auditing and qualifying new vendors.
8. Create, update, and maintain product and process specifications and QMS documentation.
9. Manage document control systems and ensure compliance with regulatory requirements.
10. Develop sampling plans, support DOE activities, and drive statistically sound quality strategies.
11. Administer training programs and maintain compliant training records.
12. Support incoming, in‑process, and final inspection planning and execution.
13. Maintain and improve systems for NCMR, CAPA, complaint handling, calibration, and supplier quality.
14. Lead investigations and root‑cause analysis for customer issues and internal quality events.
15. Mentor junior engineers and contribute to continuous improvement initiatives.
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
Senior Quality Engineer Qualifications:
16. 5+ years of Quality Engineering experience, ideally in a regulated manufacturing environment.
17. Bachelor's degree or equivalent industry experience.
18. Strong technical writing, documentation, and communication capabilities.
19. Highly organized with the ability to independently manage multiple fast‑moving projects.
20. Skilled in verification/validation activities and interpreting standards, regulations, and procedures.
21. Proficient with Microsoft Office tools; experience with instrument calibration is a plus.
22. Able to thrive under pressure and meet demanding timelines.
What's on Offer
What is on offer:
23. Work on cutting-edge medical technologies that make real‑world impact.
24. Join a rapidly expanding company with strong investment in innovation and quality.
25. Own high‑visibility projects and influence major quality system initiatives.
26. Collaborative culture with opportunities to mentor and grow into leadership.
27. Variety in day‑to‑day work - from validations to supplier quality to process optimization.