Sr Supplier Quality Engineer I

TL;DR

Sr Supplier Quality Engineer I (Supplier Quality): Conducting and overseeing supplier audits, qualifying new suppliers, and monitoring supplier performance with an accent on regulatory-quality compliance and risk reduction across the supplier lifecycle. Focus on leading CAPA execution, quality agreement management, and applying statistical and problem-solving methods to drive continuous improvement in supplier operations.

Location: Hybrid (in-office 2–3 days/week at Barnes location in San Diego, CA) and remote work

Salary: $100,000–$123,000 annually (base pay)

Company

hirify.global manufactures and sells insulin pump and diabetes management technology.

What you will do

• Manage, lead, and/or oversee supplier audits to meet company, quality, and regulatory requirements, including audits performed by third-party contractors.
• Generate, approve, review, and monitor Supplier CAPA plans and activities through investigation and closure with evidence of effectiveness.
• Qualify, manage, and monitor supplier performance; identify gaps and define/document new or improved supplier management processes.
• Partner with Quality, process owners, legal, and suppliers to create and revise Quality Agreements as needed.
• Provide supplier guidance on quality engineering disciplines and statistical/problem-solving tools (e.g., PFMEA, DMAIC, Lean, capability analysis, DOE, IQ/OQ/PQ validations).
• Report supplier quality trends to management and follow up on component non-conformances from inspections, tests, complaints, and returns.

Requirements

• Direct experience working with suppliers and contract manufacturers producing components/assemblies in a regulatory environment.
• Proficiency in Quality Engineering policies and standards, including ISO 13485, ISO 14971, ISO 9001, and related industry standards.
• Competence in QMS audit and process audit practices, including recognizing non-conformances and communicating audit results professionally.
• Strong knowledge and application of GMP principles and statistical techniques (sampling theory, probability, capability, SPC).
• Experience with problem-solving methodologies (e.g., 5-why, fault tree analysis, cause-and-effect diagrams).
• Ability to work independently and communicate effectively; understanding of mechanical drawings/specifications including GD&T.

Nice to have

• ISO lead auditor or Certified Quality Engineer (or equivalent).
• Minimum 5 years of related experience in Supplier Quality or related engineering roles.
• Experience in medical device manufacturing or FDA-regulated industry.
• Supplier/lead quality auditing experience in a regulated company and experience managing third-party contract manufacturers.
• Familiarity with PCB/PCBA, electro-mechanical assemblies, and plastic molding.

Culture & Benefits

• Hybrid schedule with 2–3 in-office days per week at the Barnes location in San Diego, CA.
• Health care benefits (medical, dental, vision) available from the first day, plus health savings and flexible spending accounts.
• 11 paid holidays per year and at least 20 days of paid time off (accrual starts on day 1).
• 401k plan with company match and an Employee Stock Purchase plan.
• 401k/benefits and compensation package includes bonus in addition to base pay.

Hiring process

• Pre-employment screening includes a drug test (excluding marijuana) and a background check.
• Conditional offer is contingent on successful completion of the screening process.