Senior Supplier Quality Engineer (Medical Devices)

Location: Irvine, California, United States; onsite five days per week. Travel to supplier locations may be required for audits, assessments, and supplier development.

Salary: $99,200–$148,800 per year in the United States, excluding Puerto Rico and specific California locations. The role is also eligible for a short-term incentive plan.

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life, serving patients across more than 150 countries.

What you will do

• Lead supplier qualification, onboarding, quality assessments, audits, documentation reviews, and supplier approvals.
• Investigate supplier-related nonconformances, complaints, and material quality issues through root cause analysis and corrective actions.
• Collaborate with Research and Development, Manufacturing, Operations Quality, and Sourcing on new product introductions, design changes, and supplier transfers.
• Monitor supplier quality performance and drive improvements in quality, delivery, reliability, and process capability.
• Support risk assessments, mitigation plans, inspection strategies, control plans, test methods, and qualification requirements.
• Conduct supplier-site validation, qualification, continuous improvement, and compliance activities.

Requirements

• Bachelor’s degree with 4+ years of relevant experience, Master’s degree with 2+ years of relevant experience, or PhD.
• Experience in supplier quality, quality engineering, manufacturing quality, or a related engineering function.
• Experience leading investigations, root cause analysis, and corrective action activities.
• Experience working within a regulated quality management system and applying quality and compliance requirements.
• Experience collaborating with cross-functional teams and external suppliers to resolve quality and process issues.
• Unrestricted U.S. work authorization is required at hiring and throughout employment; sponsorship is not available for roles below Principal level.

Nice to have

• Medical device or other highly regulated industry experience.
• Experience with new product development, design transfer, supplier development, or supplier qualification.
• Experience with supplier audits, supplier corrective action, or corrective and preventive action programs.
• Knowledge of APQP, PPAP, FMEA, SPC, MSA, DOE, or process validation.
• CQE, CSQP, Six Sigma Green Belt, or Six Sigma Black Belt certification.

Culture & Benefits

• Purpose-driven work supporting neurovascular technologies and patient outcomes.
• Health, dental, and vision insurance, plus health and dependent-care spending accounts.
• Life insurance, disability coverage, paid time off, and paid holidays.
• 401(k) plan with employer contribution and matching, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and employee assistance resources.