Senior Manager, Quality Assurance
Senior Manager, Quality Assurance
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$ 150000 - 175000
1 Vacancy
Job Description
About Us
Hyperfine Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with theSwoopsystemthe first FDA-cleared portable ultra-low-field magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Our mission is to revolutionize patient care globally through transformational accessible clinically relevant diagnostic imaging.Learn More
About The Role
Job Title: Senior Manager Quality Assurance
Location: Guilford CT USA
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.
Key Responsibilities:
- Quality Management System (QMS) Leadership: Own and drive Hyperfines QMS ensuring compliance with ISOCFR Part 820 and other applicable regulations while optimizing for scalability and efficiency.
- Document Control: Oversee the Document Management System (DMS) to ensure effective document lifecycle management controlled access and seamless usability across the organization.
- Quality Records Oversight: Manage and monitor CAPAs nonconformances complaints and training records to ensure timely resolution and compliance.
- Training Program Management: Serve as the Learning Management System (LMS) administrator to maintain effective employee training programs and compliance tracking.
- Post-Market Surveillance: Lead complaint handling adverse event determination Health Hazard Evaluations (HHEs) and support product field actions (PFAs) as needed.
- Supplier Quality Management: Manage supplier qualification audits SCARs and ensure robust oversight of critical suppliers.
- Audit & Inspection Readiness: Lead preparation for and host internal and external audits/inspections (FDA ISO Notified Bodies MDSAP TGA etc.).
- Regulatory Support: Provide quality expertise for regulatory submissions (e.g. 510(k) CE Marking) and ensure risk management processes (ISO 14971) are effectively implemented and maintained.
- Cross-Functional Collaboration: Partner closely with R&D Operations Regulatory and Clinical teams to embed quality into all aspects of product development and lifecycle management.
Knowledge Skill & Abilities
- Deep knowledge of medical device QMS requirements (ISOCFR 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.
Education & Experience:
- Bachelors 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.
Preferred Qualifications:
- 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.
Physical Demands:
- This is a full-time on-site position at Hyperfines facility in Guilford CT.
- Occasional availability during nights weekends and holidays as business needs require.
- Ability to travel up to 15% of the time for business needs (e.g. conferences site visits).
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship now or in the future of any employment Visa.
The annual base salary for this position is between $150000 - $175000. This position is also eligible for to participate in Hyperfines corporate bonus and equity plans. Individual compensation packages are based on various factors unique to each candidate including skill set relevant experience qualifications location position level and other job-related reasons.
Agency Resumes: We do not accept resumes from recruitment agencies without a prior agreement in place. Any unsolicited resumes submitted by agencies will be considered the property of Hyperfine and will not be subject to any fees or charges if the candidate is hired.
Required Experience:
Senior Manager
Employment Type
Full Time
