Sr. Supplier Quality Engineer I (Medical Devices)

Location: Hybrid in San Diego, California, with in-office work at the Barnes Canyon facility two days per week. Applicants must be authorized to work for any employer in the United States.

Base pay: $100,000–$123,000 annually, plus bonus and benefits.

Company

hirify.global develops and manufactures diabetes technology, including insulin pumps and automated insulin-delivery systems.

What you will do

• Lead and oversee supplier audits, evaluations, qualifications, change notifications, and validation activities.
• Generate, approve, and monitor supplier CAPA plans through investigation, closure, and effectiveness verification.
• Manage supplier performance and develop or improve supplier-management processes.
• Partner with Quality, process owners, legal teams, suppliers, and contract manufacturers on quality agreements and controlled manufacturing processes.
• Provide guidance on PFMECA, DMAIC, Lean, problem-solving tools, capability analysis, DOE, and IQ/OQ/PQ validations.
• Investigate component non-conformances from inspections, testing, complaints, and product returns, and report supplier quality trends to management.

Requirements

• Direct experience with suppliers and contract manufacturers producing components or assemblies in a regulated environment.
• Knowledge of ISO 13485, ISO 14971, ISO 9001, GMP, QMS audits, and process audits.
• Experience with statistical techniques including sampling theory, probability, capability analysis, and SPC.
• Experience using 5-Why analysis, fault tree analysis, cause-and-effect diagrams, and other problem-solving methods.
• Ability to work independently, influence suppliers, communicate audit findings tactfully, and implement quality improvements.
• Understanding of mechanical drawings, specifications, and GD&T.

Nice to have

• Bachelor’s degree in Engineering, preferably Electromechanical Engineering, or equivalent education and experience.
• At least five years of related Supplier Quality or engineering experience.
• ISO lead auditor or Certified Quality Engineer certification.
• Experience with PCB, PCBA, electromechanical assemblies, plastic molding, medical-device manufacturing, FDA-regulated industries, or third-party contract manufacturers.

Culture & Benefits

• Medical, dental, and vision coverage available from the first day.
• Health savings and flexible spending accounts.
• At least 20 days of paid time off and 11 paid holidays per year.
• 401(k) plan with company match and Employee Stock Purchase Plan.
• Employment is contingent on drug testing and a background check.