About The Role

Job Title: Supplier Quality Engineer

Location:Guilford, Connecticut

SUMMARY:

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. 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.
• 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

KNOWLEDGE AND SKILL:

• 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.

EDUCATION/EXPERIENCE REQUIRED:

• 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.

PREFERRED QUALIFICATIONS:

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

PHYSICAL DEMANDS:

• Ability to sit, stand, walk, and perform computer-based work for extended periods
• Ability to use standard office equipment, including computers, telephones, printers, and scanners.
• Ability to work in manufacturing, warehouse, and supplier environments while complying with applicable safety and personal protective equipment requirements
• Ability to occasionally lift and carry materials weighing up to 25 pounds.
• Ability to periodically access manufacturing, warehouse, and supplier facilities.
• Ability to travel domestically and internationally, as required. (Up to 15% travel)
• Ability to work additional hours as needed to support audits, supplier activities, and business objectives.

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 $107,000 - $123,000. This position is also eligible for to participate in Hyperfine's 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.