Hyperfine

Hyperfine

Supplier Quality Engineer

Guilford, Connecticut

Sponsorship not specifiedDetected 2 days ago
Data AnalysisStatisticsAuditingProcess ImprovementERPPatient CareFDA RegulatoryMedical DevicesLeadershipCommunicationProblem SolvingWritingMicrosoft Office

About the role

  • Job Title: Supplier Quality Engineer
  • 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.

Responsibilities

  • Establish and maintain Supplier Qualification process and associated documentation, including supplier audits, supplier agreements, the Approved Supplier List, and supplier scorecards.
  • 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
  • Provide leadership, guidance, and analytical expertise to support the robust manufacturing and evaluation of Hyperfine products, ensuring quality standards are achieved, applicable regulatory requirements are maintained, and opportunities for continuous improvement and standardization are realized.

Requirements

  • Proficiency with MS Office, ERP systems, and eQMS platforms.

Nice to have

  • 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.

Benefits

  • Strong working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 principles, and applicable medical device regulatory requirements.

Company info

  • Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system-the 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
  • Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop ® system-the 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.
Apply directly at Hyperfine →Create a free account for alerts like thisView Hyperfine immigration profile

This listing is sourced directly from Hyperfine's careers page and normalized into a canonical job model.