Senior Manager, Quality Assurance

Hyperfine • Guilford, CT

183d • $150,000 - $175,000

About The Position

As Senior Manager of Quality Assurance, you will lead the development, implementation, and continuous improvement of our Quality Management System (QMS) to ensure compliance with global regulatory requirements and support our mission of expanding access to MRI. This is a hands-on leadership role requiring a balance of strategic oversight and operational execution.

Requirements

• Deep knowledge of medical device QMS requirements (ISO 13485, 21 CFR 820) and global regulatory standards (EU MDR, MDSAP, IEC 62304, IEC 60601).
• Proven experience in Software Quality Assurance and medical device software lifecycle processes.
• Demonstrated success in leading audits and regulatory inspections (FDA, ISO Notified Bodies, etc.).
• Strong background in post-market surveillance and risk management.
• Excellent problem-solving, decision-making, and communication skills with the ability to navigate complex technical and regulatory issues.
• Bachelor's degree in engineering, life sciences, or a related technical discipline (advanced degree preferred).
• Lead Auditor certification for ISO 13485:2016.
• Minimum 4 years in a QA leadership role within the medical device industry, with proven experience maintaining compliance to ISO 13485:2016 and 21 CFR Part 820.
• Minimum 10 years of progressive experience in quality assurance roles in the medical device sector, including Class II and/or Class III devices.

Nice To Haves

• Experience with portable imaging devices or complex electromechanical systems.
• Participation in successful 510(k) submissions and CE Marking of Class II or III devices.
• Familiarity with human factors engineering and usability studies in the medical device context.

Responsibilities

• Own and drive Hyperfine's QMS, ensuring compliance with ISO 13485, 21 CFR Part 820, and other applicable regulations while optimizing for scalability and efficiency.
• Oversee the Document Management System (DMS) to ensure effective document lifecycle management, controlled access, and seamless usability across the organization.
• Manage and monitor CAPAs, nonconformances, complaints, and training records to ensure timely resolution and compliance.
• Serve as the Learning Management System (LMS) administrator to maintain effective employee training programs and compliance tracking.
• Lead complaint handling, adverse event determination, Health Hazard Evaluations (HHEs), and support product field actions (PFAs) as needed.
• Manage supplier qualification, audits, SCARs, and ensure robust oversight of critical suppliers.
• Lead preparation for, and host, internal and external audits/inspections (FDA, ISO Notified Bodies, MDSAP, TGA, etc.).
• Provide quality expertise for regulatory submissions (e.g., 510(k), CE Marking) and ensure risk management processes (ISO 14971) are effectively implemented and maintained.
• Partner closely with R&D, Operations, Regulatory, and Clinical teams to embed quality into all aspects of product development and lifecycle management.

Benefits

• Annual base salary between $150,000 - $175,000.
• Eligibility to participate in Hyperfine's corporate bonus and equity plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees