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Quality manager- medical device- clinton, ma

Weybridge
Permanent
Michael Page Sales
Quality manager medical devices
Posted: 16 May
Offer description

Job Description

1. Maintain and continuously improve a robust Quality Management System compliant with ISO 9001:2015 and ISO 13485.
2. Act as Management Representative, reporting on quality system performance and compliance to senior leadership.
3. Lead internal audits, CAPA processes and Management Review activities.
4. Design and implement systems for ongoing production quality monitoring and control.
5. Analyse quality data and trends, producing clear reports to support decision‑making and resource allocation.
6. Partner with production and engineering teams to implement new testing criteria, inspection methods and assembly processes.
7. Establish and maintain product, process and raw material quality standards, working closely with suppliers as required.
8. Oversee in‑process and final product inspection activities, including dimensional, visual and functional checks.
9. Manage customer complaint handling and medical device reporting systems, ensuring effective corrective actions.
10. Lead APQP, PPAP and validation activities (IQ/OQ/PQ) for new and transferred projects.
11. Manage and develop supplier quality processes and performance.
12. Supervise and develop the Quality team, including performance management, training and day‑to‑day direction.

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

13. Bachelor's degree in Engineering or a related technical discipline.
14. 5+ years' experience in a manufacturing environment in a Quality Engineering or Quality Management role.
15. Strong working knowledge of ISO 9001 and ISO 13485 quality systems.
16. Experience leading audits, CAPA, Management Review and validation activities.
17. Strong understanding of SPC, GD&T and metrology tools (calipers, micrometers, CMM, vision systems, etc.).
18. Proven leadership experience with the ability to manage and develop quality teams.
19. Experience in regulated manufacturing environments such as medical devices preferred.

What's on Offer

20. Leadership role with real authority over quality systems and strategy
21. High visibility with senior management and cross‑functional teams
22. Exposure to regulated manufacturing and complex quality requirements
23. Opportunity to lead, mentor and build a quality team
24. Stable organisation that values quality, compliance and continuous improvement

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