Job Description
1. Drive product and process quality using statistical tools, audits, and structured problem-solving methodologies
2. Lead and maintain process validations, including PFMEAs, OQ/PQ, PPAPs, FAIRs, and validation reports
3. Manage MRB activities, NCRs, and CAPA, ensuring effective corrective actions and follow-up
4. Analyse manufacturing and validation data to reduce variation, waste, and defects
5. Review and control internal and external changes, including customer specifications
6. Support ERP-related activities including route and BOM approvals
7. Lead and support software validation activities, including test cases and validation documentation
8. Investigate customer complaints using structured root cause analysis techniques
9. Support internal, customer, and registrar audits as required
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.
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
10. Bachelor's degree in Engineering or a related technical/scientific discipline
11. 1-3 years' experience in a medical device manufacturing environment
12. Strong working knowledge of ISO 13485:2016 and familiarity with FDA CFR Part 820
13. Hands-on experience with process, product, and software validation
14. Strong analytical skills; experience with statistical tools (Minitab preferred)
15. Experience with ERP systems and a fast-paced manufacturing environment
16. Excellent written and verbal communication skills
What's on Offer
17. High-impact role with real ownership of quality and validation activities
18. Exposure across engineering, manufacturing, and operations
19. Opportunity to strengthen regulated industry expertise
20. Strong emphasis on continuous improvement and best practices
21. Stable environment with long-term growth potential