Senior Quality Assurance Engineer, Medical Devices

Senior Quality Assurance Engineer – Medical Devices (Contract to Hire) Location: Remote Hours: 20–30 hours/week (Contract) Senior Quality Assurance Engineer to support medical device clients across the full product lifecycle. This is an opportunity to join a growing consulting firm where your expertise will directly influence client success and company growth. Responsibilities Implement and improve FDA QMSR/ISO 13485 Quality Systems Lead Design Control activities and maintain Design History Files Develop Risk Management documentation (ISO 14971) Create Design Traceability Matrices Conduct supplier qualification and quality audits (desk and on-site) Lead CAPA, nonconformance, and continuous improvement initiatives Support manufacturing quality and Design Transfer Participate in Design Reviews and Post-Market Surveillance Support FDA and EU MDR regulatory activities Build strong client relationships and serve as a trusted quality advisor Support FDA and EU MDR regulatory activities, with the opportunity to expand Regulatory Affairs knowledge and responsibilities over time Qualifications: Bachelor's degree in Engineering or related field 5+ years in medical device Quality Assurance Strong knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, and ISO 14971 Experience implementing Quality Management Systems Excellent communication and technical writing skills ASQ CQA or CMDA certification strongly preferred