Senior Supplier Quality Engineer

irhythmtech; California (MO); Hybrid; USD 120,000 - 180,000; Full time

Job summary

iRhythm is seeking a Senior Supplier Quality Engineer to lead the quality lifecycle across our global supplier base. You will ensure components and materials meet ISO 13485 standards and our strict specifications, acting as the primary quality interface with suppliers and manufacturing partners.

You will partner with Engineering, Sourcing, and Production to drive PPAP, MRB, and SCAR processes, and lead data-driven root-cause analyses in a fast-paced, high-growth environment.

Qualifications

• Minimum 5 years in Quality/Manufacturing Engineering or Quality Engineering in medical devices.
• Experience with ISO 13485, FDA, EUMDR requirements and quality systems.
• Strong data-driven problem solving (Six Sigma, DOE, IQ/OQ/PQ).

Responsibilities

• Lead supplier audits and qualification per ISO 9001/13485.
• Own MRB and NCR disposition to protect production lines.
• Manage SCARs and drive permanent corrective actions with suppliers.
• Lead PPAP activities and ensure process capabilities meet requirements.
• Develop supplier scorecards and drive continuous improvement with Lean/Six Sigma.
• Collaborate with Engineering, Sourcing, and Production during NPI and production readiness.

Skills

Quality engineering

Supplier quality

Root cause analysis

Six Sigma

DFMEA/PPAP

Education

Lead Auditor Certified (ISO 13485)

Tools

PPAP

Gage R&R

Job description

Career-defining. Life-changing.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

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.

Essential Duties and Responsibilities:

• Supplier Audits & Qualification: Conduct rigorous risk assessments and quality system audits (e.g., ISO 9001, ISO 13485) at supplier facilities to qualify suppliers.
• Conducting Component Qualification: 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.
• Non-Conformance Control: 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.
• Agile SCAR Ownership: Issue and manage formal Supplier Corrective Action Requests (SCARs) for high-risk failures. Drive suppliers to permanent resolution.
• Root Cause Analysis: 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.
• New Product Introduction (NPI): 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.
• Performance Monitoring: Analyze quality metrics (DPPM, SCAR response time, yield rates) to generate monthly supplier scorecards and run quarterly business reviews (QBRs) for critical vendors.
• Continuous Improvement: Initiate cost-reduction, yield-improvement, and process-capability (Cpk) projects alongside suppliers using Six Sigma and Lean methodologies.

Experience and Minimum Qualifications:

• Education: Minimum bachelor's degree in Mechanical, Electrical, Industrial Engineering, or a related technical field.
• Experience: 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.
• Certification: Lead Auditor Certified (ISO 13485)

Knowledge, Skills and Abilities:

• Direct experience in the Medical Device industry (ISO13485, FDA, EUMDR)
• 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.
• Lead Auditor Certified, ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or a Six Sigma Green/Black Belt certification.
• Experience managing specialized manufacturing processes like PCBA, injection molding, batteries, CNC machining, casting.

Work Environment / Other Requirements:

• 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.
• Physical Requirements: Ability to remain in a stationary position for extended periods, operate a computer and standard office equipment, communicate effectively in meetings and supplier interactions, and occasionally stand, walk, or move within manufacturing and supplier environments during audits or inspections.