Senior Supplier Quality Engineer

TL;DR

Senior Supplier Quality Engineer: Ensuring externally sourced materials, components, and services meet hirify.global quality and regulatory requirements with an accent on supplier qualification, nonconformance investigations, and corrective/preventive actions. Focus on driving sustainable root-cause solutions, monitoring supplier performance via metrics, and supporting new product introductions and design changes for Neurovascular products manufactured in Irvine, CA.

Company

hirify.global is a global healthcare technology company focused on engineering solutions that alleviate pain, restore health, and extend life.

What you will do

• Ensure suppliers deliver quality parts, materials, and services throughout the acquisition-to-manufacturing cycle.
• Qualify and onboard suppliers, including quality assessments, audits, and documentation review.
• Lead investigations for supplier-related nonconforming material and complaints, performing root cause analysis and implementing CAPA with suppliers.
• Support new product introductions and design changes, including pre-market supplier quality activities across the NPD lifecycle.
• Collaborate on product acceptance sampling strategy, approved supplier list coordination, supplier-owned quality deployment, and control plans.
• Define receiving inspection requirements and support test method validation, risk management, and quality objectives with R&D and manufacturing engineering.

Requirements

• Location: Onsite in Irvine, California, United States (minimum 5 days/week onsite).
• Requires a Baccalaureate degree with minimum 4 years of relevant experience, or a Master’s degree with minimum 2 years, or a PhD with 0 years.
• U.S. work authorization required at time of hire; sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above.
• Experience in supplier quality, including leading supplier audits and resolving supplier-related quality issues.
• Ability to analyze supplier quality metrics and drive continuous improvement initiatives.

Nice to have

• Experience in medical device or other highly regulated industries (FDA, ISO 13485, MDR).
• ASQ certifications (CQE, CSQP) and/or Six Sigma Black/Green Belt.
• Familiarity with risk management methodologies such as ISO 14971 and FMEA.
• Experience with advanced quality tools (SPC, MSA, DOE, capability analysis) and supplier corrective action systems (SCAR/CAPA).
• Experience with APQP, PPAP, control plan development, and/or QMS platforms (TrackWise, MasterControl, SAP).

Culture & Benefits

• Onsite role with a minimum of 5 days/week in-person collaboration.
• Salary range for U.S. locations (excluding Puerto Rico): $99,200–$148,800 (USD).
• Eligible for short-term incentive (hirify.global Incentive Plan, MIP).
• Benefits for regular employees working 20+ hours/week include health, dental, vision, HSA, healthcare FSA, life insurance, long-term disability, dependent daycare spending account, and tuition assistance.
• Additional benefits for all regular employees include 401(k) with employer contribution and match, paid time off, paid holidays, and employee assistance program.