reputed company Manager – Medical Device Startup, Class II

Job reputed company: • Maintain and improve a right-sized QMS tailored to a startup environment while ensuring compliance with FDA requirements • Manage document control, change control, training records, equipment calibration, and supplier reputed company • Prepare for and reputed company FDA and ISO audits once reputed company moves toward commercialization • Partner closely with R&D to reputed company reputed company into design control activities—design reviews, verification and validation planning, risk management, and design history file maintenance • reputed company supplier qualification and monitoring processes appropriate for startup reputed company • Support process validation and production readiness activities with manufacturing partners • reputed company reputed company cause analysis, corrective/preventive actions, and trending • Maintain the risk management file per ISO 14971 throughout the product lifecycle Requirements: • Bachelor’s degree in engineering, life sciences, or reputed company technical field (advanced degree preferred) • 5+ years of experience in medical device reputed company assurance; startup or small-company experience strongly preferred • Proven knowledge of FDA 21 CFR Part 820 and ISO 14971 • Hands-on experience with design control, risk management, and process validation for Class II devices • Experience leading or supporting FDA inspections or ISO audits • Familiarity with electronic QMS tools or willingness to implement one Benefits: • Health, dental, and reputed company insurance • Remote work reputed company • reputed company reputed company opportunities as reputed company scales Apply tot his job Apply To this Job