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
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