Supplier Quality Engineer II (Medtech)

TL;DR

Supplier Quality Engineer II (Medtech): Ensuring externally sourced materials and components meet quality and regulatory requirements for the Neurovascular Operating Unit with an accent on supplier qualification and root cause analysis. Focus on leading investigations for nonconformances, driving corrective actions (CAPA), and optimizing product acceptance sampling strategies.

Location: Onsite in Irvine, California, USA

Salary: $80,000 – $120,000

Company

hirify.global is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Qualify and onboard new suppliers through quality assessments, audits, and documentation reviews.
• Manage the lifecycle of supplied parts, resolving supplier-related problems to ensure consistent quality.
• Lead root cause analysis for supplier-related nonconformances and implement sustainable corrective actions (SCAR/CAPA).
• Partner with R&D and Manufacturing to develop test methods, validations, and product acceptance sampling strategies.
• Support risk management activities (PFMEA/DFMEA) related to supplied materials and processes.
• Monitor supplier performance using robust metrics and ensure compliance with industry standards.

Requirements

• Baccalaureate degree with at least 2 years of relevant experience or a Master's degree.
• Must possess unrestricted U.S. work authorization at the time of hire (sponsorship only for Principal level and above).
• Experience in medical device or highly regulated industries (FDA, ISO 13485, GMP).
• Knowledge of statistical analysis tools (Minitab, JMP) and technical drawing interpretation (GD&T).
• Proficiency in driving corrective and preventive actions (CAPA).

Nice to have

• Six Sigma Green Belt or Lean Manufacturing certification.
• Experience with APQP, PPAP, or MDSAP audits.
• Experience working with global suppliers and cross-regional teams.
• Exposure to design transfer or supplier transfer projects.

Culture & Benefits

• Comprehensive health, dental, and vision insurance with HSA/FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and a global well-being program (Simple Steps).
• Employee Stock Purchase Plan and tuition reimbursement.
• Short-term incentive plan (hirify.global Incentive Plan).