Supplier Quality Engineer

Hyperfine•Guilford, CT

6d•$107,000 - $123,000•Onsite

About The Position

Hyperfine, Inc. is seeking a Supplier Quality Engineer to provide leadership, guidance, and analytical expertise to support the robust manufacturing and evaluation of Hyperfine products. This role ensures quality standards are achieved, applicable regulatory requirements are maintained, and opportunities for continuous improvement and standardization are realized. The Supplier Quality Engineer will serve as the primary quality representative for suppliers, establishing quality expectations, monitoring supplier performance, and driving the resolution of quality and compliance issues to ensure that products consistently meet Hyperfine’s quality and regulatory requirements.

Requirements

Strong working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 principles, and applicable medical device regulatory requirements.
Demonstrated leadership in supplier quality management, supplier audits, Nonconformance and CAPAs/SCARs, and risk management activities.
Experience planning, conducting, and managing supplier audits, including audit reporting, follow-up, and effectiveness verification.
Strong analytical and problem-solving skills including Root Cause Analysis, CAPA, Change Management, Risk Management and Six Sigma methodologies, statistical analysis, and data-driven decision making.
Proficiency with MS Office, ERP systems, and eQMS platforms.
Ability to communicate effectively and influence stakeholders across all levels of the organization and with external suppliers.
Strong technical writing, communication, and data analysis skills.
BA/BS degree in a technical discipline preferred. Equivalent experience may be considered in lieu of higher degree.
5 - 7 years of experience in a quality role within a regulated industry, preferably including supplier auditing and supplier management.
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.

Nice To Haves

ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) or Certified Six Sigma Green Belt (CSSGB)
ISO 13485 or MDSAP auditor training.

Responsibilities

Establish and maintain Supplier Qualification process and associated documentation, including supplier audits, supplier agreements, the Approved Supplier List, and supplier scorecards.
Conduct product release activities, including review and approval of Supplier Device History Records (DHRs).
Collaborate with Operations, Engineering, and R&D to ensure that the products produced meet applicable quality and regulatory requirements, including risk assessment and disposition of deviations, rework activities, Visual Assembly Process (VAP) documentation.
Analyze supplier quality and internal manufacturing performance metrics to identify trends, drive continuous improvement initiatives, and support process standardization efforts.
Own and manage Nonconformances (NCs), Corrective and Preventive Actions (CAPAs) and Supplier Corrective Action Requests (SCARs), as assigned.
Support the maintenance of Quality System documentation, as necessary.
Support and participate in Internal and External Audits, as necessary.