Aegis Ventures - Senior QA/RA Specialist
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Requirements
• 7+ years of medical device quality assurance and regulatory affairs experience • Demonstrated experience supporting FDA 510(k) submissions • Proven track record managing contract manufacturer relationships and supplier quality • Experience conducting supplier audits and managing complex CAPA investigations • Hands-on experience with design controls and DHF maintenance for Class II devices • Expert knowledge of FDA regulations (21 CFR Part 820, Part 11, 510(k) pathway) • Strong understanding of ISO 13485 quality management system requirements • Proficiency in risk management per ISO 14971 • Working knowledge of design control requirements and V&V best practices • Experience with complaint handling and MDR reporting • Experience with hardware medical devices (optical devices, cameras, or imaging systems) is preferred • Experience working with Asian contract manufacturers, particularly in China is preferred • Background in both software and hardware medical device environments is preferred • Ability to work independently with minimal oversight and strong decision-making capability • Excellent written and verbal communication skills for regulatory submissions and audits • Strong project management skills with ability to manage multiple priorities • Analytical mindset for root cause analysis and problem-solving • Collaborative approach to working with engineering, operations, and international teams
Responsibilities
• Support regulatory strategy and submission timelines for US market • Support management of medical device listing, establishment registration, and labeling compliance • Own quality oversight of supplier relationships for US market • Conduct supplier audits (remote and on-site) and manage audit findings to closure • Lead CAPA investigations and effectiveness verification • Manage incoming inspection criteria and supplier performance metrics • Coordinate design transfer and manufacturing scale-up activities • Maintain design control documentation (DHF) for hardware products • Handle complaint investigations and MDR reporting • Support document control and training record maintenance • Partner with Engineering on design verification/validation protocols • Work with Operations on manufacturing quality requirements • Coordinate with Director of QA/RA on global compliance strategy
Benefits
• Competitive compensation package, including a strong base salary, performance-based bonus, and the chance to earn upside. • Top-tier health, vision, dental, and commuter benefits. • Generous monthly health and wellness reimbursement. • Unparalleled exposure to new business building at the intersection of artificial intelligence and healthcare. • The opportunity to help solve difficult problems and collaborate with world-class experts from healthcare provider networks, academia, and industry. • A chance to work with a highly talented, close-knit team and world-leading mentors who can act as a support network and sounding board throughout your entrepreneurial journey. • $85,000 - $115,000 base salary, depending on experience and alignment with role expectations. • Why Optain? Make a real difference: Your work will help solve difficult problems as you collaborate with world-class experts from healthcare provider networks, academia, and industry. Join Optain in transforming healthcare with AI!
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