Supplier Quality Engineer

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 More

About The Role

Job Title: Supplier Quality Engineer

Location:Guilford Connecticut

SUMMARY:

Provide leadershipguidanceand analyticalexpertisetosupport therobust manufacturing and evaluation of Hyperfine productsensuringquality standards are achievedapplicable regulatory requirements aremaintainedand opportunities forcontinuous improvement and as the primary quality representative for suppliersestablishingquality expectations monitoring supplier performance and driving the resolution of quality and compliance issues to ensurethat products consistentlymeetHyperfinesquality and regulatory requirements.

RESPONSIBILITIES:

• Establish andmaintainSupplierQualificationprocessand associated documentationincludingsupplier auditssupplier agreements theApprovedSupplierListandsupplier scorecards.
• Conduct product release activities including review and approval of Supplier Device History Records (DHRs)
• Collaborate with Operations Engineering and R&Dto 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 820ISO 13485 ISO 14971principlesand 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 be consideredin lieu of higherdegree.5 - 7 yearsofexperience in a quality rolewithin a regulated industrypreferably including supplier auditing and supplier management.

PREFERRED QUALIFICATIONS:

• ASQCertified Quality Auditor (CQA)Certified Quality Engineer (CQE)orCertified 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
• Abilityto 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 $107000 - $123000. 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.