Senior Supplier Quality Engineer (Medical Devices)

Location: Orange County, California, United States. Hybrid schedule with 2–3 days per week in the office; travel up to 25% domestically and internationally to supplier sites.

Estimated pay range: $99,000–$129,000 per year.

Company

hirify.global is a digital healthcare company developing wearable biosensors, cloud-based data analytics, and proprietary algorithms for cardiac monitoring and disease detection.

What you will do

• Conduct supplier risk assessments, quality system audits, and supplier qualification activities, including ISO 9001 and ISO 13485 audits.
• Lead and approve PPAP activities, including process validation, test method validation, PFMEA, control plans, and process capability reviews.
• Own the supplier material review process and manage non-conforming materials, NCRs, and containment actions.
• Issue and manage SCARs, lead root-cause investigations, and drive suppliers toward permanent corrective actions.
• Partner with Engineering on NPI, CTQ characteristics, inspection alignment, and supplier capability evaluation.
• Monitor DPPM, SCAR response time, yield, and supplier scorecards while leading cost, yield, and process-capability improvements.

Requirements

• Bachelor’s degree in Mechanical, Electrical, Industrial Engineering, or a related technical field.
• At least 5 years of Quality or Manufacturing Engineering experience with a bachelor’s degree, or 3 years with a master’s degree.
• Direct medical device industry experience with ISO 13485, FDA, and EU MDR requirements.
• Experience with process capability studies, DOE, IQ/OQ/PQ validations, Gage R&R, and process control strategies.
• Experience leading root-cause investigations and sustainable corrective actions, with strong supplier negotiation and cross-functional collaboration skills.
• Ability to travel up to 25% and hold a valid passport; experience with PCBA, injection molding, batteries, CNC machining, or casting is relevant.

Nice to have

• ISO 13485 Lead Auditor, ASQ CQE, CQA, or Six Sigma Green/Black Belt certification.
• Experience working with contract manufacturers or third-party suppliers.

Culture & Benefits

• Fast-paced, high-growth environment with high-volume production and rapid product development cycles.
• Collaboration with Engineering, Sourcing, Production, suppliers, and manufacturing partners.
• Opportunity to contribute to cardiac health products and patient-focused healthcare solutions.
• Hybrid work arrangement with regular office presence and supplier-site travel.