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Medical Device Quality Principal
PharmathenSenior leadership role for defining and driving global quality strategy for medical devices at Pharmathen. Ensuring regulatory compliance and business growth while safeguarding patient safety.
About the role
Key responsibilities & impact- Own the enterprise Medical Device Quality Management System (QMS) and ensure global regulatory compliance (FDA, EU MDR, ISO 13485, ISO 14971, and other applicable frameworks)
- Provide end-to-end quality oversight across design, development, transfer, commercialization, and post-market activities
- Act as the ultimate decision authority for critical quality and compliance matters, including risk management, CAPAs, deviations, and change control
- Drive supplier quality strategy and oversight of critical external partners and CMOs
- Partner with R&D, Regulatory, Manufacturing, and Supply Chain to ensure quality is embedded across the value chain
Requirements
What you’ll need- Advanced degree in Life Sciences, Engineering, Pharmacy, or a related scientific field
- Extensive experience in medical device quality within a global regulated environment
- Strong expertise in FDA, EU MDR, ISO 13485, and ISO 14971
- Proven leadership in global or enterprise-level roles
- Experience interacting with regulatory authorities and leading inspections
Benefits
Comp & perks- Involvement in a high-caliber, team-oriented and dynamic atmosphere
- Exposure to challenging business issues and practices
- Great opportunity to leverage and develop your business/scientific knowledge and skills
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Medical Device Quality Management System (QMS)regulatory compliancerisk managementCAPAsdeviationschange controlsupplier quality strategyquality oversightdesign and developmentpost-market activities
Soft Skills
leadershipdecision authoritycollaborationcommunicationinterpersonal skills