Aegis Ventures · 6 days ago
Senior QA/RA Specialist
United States
Full-time
Remote
Mid, Senior Level
$85K/yr - $115K/yr
7+ years expAegis Ventures partners with entrepreneurs and industry leaders to launch and scale transformative companies in digital health and artificial intelligence. The Senior QA/RA Specialist will own quality and regulatory operations for the US hardware product line, ensuring compliance with FDA regulations and supporting post-market activities.
Artificial Intelligence (AI)Health Care
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
Qualification
Required
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
Preferred
Experience with hardware medical devices (optical devices, cameras, or imaging systems)
Experience working with Asian contract manufacturers, particularly in China
Background in both software and hardware medical device environments
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.
Company
Aegis Ventures
Reimagining entrepreneurship for the next generation of builders and problem-solvers
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Daniel Towbin
Director, Strategic Programs & Events
John Driscoll
Venture Partner
Recent News
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