Medical Device Quality Principal

Role Overview

• 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

• 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

• 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