Supplier Quality Engineer (Medtech)

TL;DR

Supplier Quality Engineer (Medtech): Managing and evaluating supplier performance to ensure the robust manufacturing of portable MRI systems with an accent on regulatory compliance and quality standards. Focus on establishing supplier qualification processes, conducting audits, and driving the resolution of quality and compliance issues via CAPA and SCAR.

Location: Guilford, Connecticut. Applicants must be authorized to work for any employer in the U.S. (no sponsorship available now or in the future)

Salary: $107,000 - $123,000

Company

hirify.global is a health technology company that has redefined brain imaging with the first FDA-cleared portable, ultra-low-field MRI system.

What you will do

• Establish and maintain the Supplier Qualification process, including audits, agreements, and supplier scorecards.
• Review and approve Supplier Device History Records (DHRs) for product release.
• Collaborate with Operations, Engineering, and R&D on risk assessments and the disposition of deviations.
• Own and manage Nonconformances (NCs), Corrective and Preventive Actions (CAPAs), and Supplier Corrective Action Requests (SCARs).
• Analyze quality metrics to identify trends and drive continuous improvement and process standardization.
• Support and participate in internal and external quality audits.

Requirements

• 5-7 years of experience in a quality role within a regulated industry, including supplier auditing and management.
• Strong working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971 principles.
• Expertise in Root Cause Analysis, Change Management, and Six Sigma methodologies.
• Must be authorized to work in the U.S. without sponsorship.
• Ability to travel domestically and internationally (up to 15%).
• Proficiency with MS Office, ERP systems, and eQMS platforms.

Nice to have

• ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or Certified Six Sigma Green Belt (CSSGB).
• ISO 13485 or MDSAP auditor training.
• BA/BS degree in a technical discipline.

Culture & Benefits

• Competitive annual base salary.
• Eligibility for corporate bonus and equity plans.
• Opportunity to work with groundbreaking, FDA-cleared portable MRI technology.
• Mission-driven environment focused on revolutionizing global patient care.