Senior Supplier Quality Engineer

iRhythm • Orange County, CA

2d • Hybrid

About The Position

The Senior Supplier Quality Engineer (Sr. SQE) ensures that the global supply chain delivers components, assemblies, and materials that meet all technical specifications and quality standards. This role thrives in a fast-paced, high-growth environment characterized by high-volume production schedules and rapid product development cycles. You will serve as the primary quality interface between our suppliers and manufacturing partners. This role requires technical leadership, data-driven defect reduction, and extensive collaboration with Engineering, Sourcing, and Production teams to mitigate risk before parts hit the manufacturing floor.

Requirements

• Minimum bachelor’s degree in Mechanical, Electrical, Industrial Engineering, or a related technical field.
• Minimum of 5 years of experience with a bachelor’s degree, or 3 years with master’s degree, in Quality Engineering, or Manufacturing Engineering with hands-on experience.
• Direct experience in the Medical Device industry (ISO13485, FDA, EUMDR) required.
• Strong technical expertise executing, validations, including process capability studies (DOE, IQ, OQ, PQ), Gage R&R studies, and process control strategies.
• Proven track record of operating successfully in a fast-paced environment with minimal supervision and high ambiguity.
• Proven track record of independently leading formal root-cause analysis investigations and deploying sustainable corrective actions.
• Exceptional cross-functional collaboration with negotiation skills, with the ability to confidently influence external supplier leadership and internal executives under high-pressure situations.
• Experience managing specialized manufacturing processes like PCBA, injection molding, batteries, CNC machining, casting.

Nice To Haves

• Lead Auditor Certified (ISO 13485) OR ASQ Certified Quality Engineer (CQE) OR Certified Quality Auditor (CQA) OR a Six Sigma Green/Black Belt certification preferred.
• Experience working with Contract Manufacturers/3rd Party Suppliers preferred.
• Candidate must poses a passport.

Responsibilities

• Conduct rigorous risk assessments and quality system audits (e.g., ISO 9001, ISO 13485) at supplier facilities to qualify suppliers.
• Lead, review, and approve the end-to-end Production Part Approval Process (PPAP). Actively participate in conducting PPAP activities with suppliers—including Process Validation, Test Method validation, reviewing Process Flow Diagrams, Process FMEAs (PFMEA), Control Plans, to validate process capability before production release.
• Own the Material Review Board (MRB) process for supplier materials. Rapidly isolate, contain, and disposition non-conforming parts (NCRs) to minimize production downtime and protect assembly line velocity.
• Issue and manage formal Supplier Corrective Action Requests (SCARs) for high-risk failures. Drive suppliers to permanent resolution.
• Champion data-driven problem-solving methodologies—including 5-Whys, Fishbone diagrams, and Six Sigma—to quickly diagnose and solve complex technical defects under high-pressure conditions.
• Partner with Engineering during design phases to evaluate supplier capability, establish critical-to-quality (CTQ) characteristics, and establish inspection alignments between internal and vendor sites.
• Analyze quality metrics (DPPM, SCAR response time, yield rates) to generate monthly supplier scorecards and run quarterly business reviews (QBRs) for critical vendors.
• Initiate cost-reduction, yield-improvement, and process-capability (Cpk) projects alongside suppliers using Six Sigma and Lean methodologies.

Benefits

• Hybrid schedule with 2–3 days per week in the office, based on business needs and team requirements.
• Travel up to 25% domestically and internationally to visit supplier sites for audits and critical problem-solving sessions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior