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Summary
About the Role
About You
- 6–7+ years in medical device Quality Engineering (10+ preferred).
- Strong hands-on manufacturing experience.
- Proven leadership or people management background.
- Deep problem-solving ability and engineering mindset.
- Experience with CAPA, root cause analysis, validations, and risk management.
- Solid understanding of FDA QMSR, ISO 13485, EU MDR.
Benefits
- High ownership of quality at a commercial-scale facility.
- Leadership opportunity with room to grow.
- Collaborative, fast-paced environment with real engineering challenges.
- Direct visibility with Operations and senior leadership.
- Chance to shape processes, not just maintain them.
Pragmatic Certified is designed to guide you through the minefield of Life Sciences Recruitment. Pragmatic Certified streamlines Life Sciences Recruitment for companies in medical devices, and biotech, from groundbreaking research to market-leading products. Our network, years of experience, and award-winning technology give us an unmatched ability to introduce great candidates. Pragmatic offers exclusive, retained and project solutions in the following areas: Leadership: We place visionary C-Suites, VPs, & Directors Quality Engineering & Technical Operations: Specializing in top-tier Engineers and Technical Specialists, we ensure innovation and product excellence. Clinical & Research Excellence: Providing experts in Project Management and Site Coordination for successful trials and studies. MedTech: Matching industry-leading MedTech professionals to advance healthcare technology and patient care. HQ:+1 512 717 7556 w: www.pragmaticresource.com e: hello@pragmaticresource.com