Quality Manager – Medical Device Startup, Class II
Job Description: • 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 quality • Prepare for and lead FDA and ISO audits once the company moves toward commercialization • Partner closely with R&D to embed quality into design control activities—design reviews, verification and validation planning, risk management, and design history file maintenance • Develop supplier qualification and monitoring processes appropriate for startup scale • Support process validation and production readiness activities with manufacturing partners • Lead root 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 related technical field (advanced degree preferred) • 5+ years of experience in medical device quality 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 vision insurance • Remote work option • Professional growth opportunities as the company scales Apply tot his job