Senior Supplier Quality Engineer

Regulatory Jobs; California; Hybrid; USD 99,000 - 129,000; Full time

Benefits offered by this job

Hybrid schedule

Travel opportunities

Job summary

iRhythm Technologies in Orange County is seeking a Senior Supplier Quality Engineer to lead quality across global supplier networks, ensuring parts meet ISO9001/13485 standards and feed production lines with reliable components. You will audit suppliers, drive PPAP, lead MRB, and collaborate with Engineering, Sourcing, and Production to reduce defects.

Hybrid schedule, travel up to 25%, and a focus on Six Sigma and continuous improvement.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering.
• 5+ years experience in Quality or Manufacturing Engineering (3 years with master’s).
• Lead Auditor ISO 13485 / ASQ CQE / CQA or Six Sigma Green/Black Belt preferred.
• Experience in Medical Device industry (ISO13485, FDA, EUMDR) required.
• Experience with Contract Manufacturers/3rd Party Suppliers preferred.

Responsibilities

• Perform supplier audits and qualification to qualify suppliers.
• Lead PPAP activities and process validation.
• Own MRB process to manage non-conforming parts.
• Issue supplier corrective actions (SCARs) and drive permanent resolution.
• Conduct root cause analysis using 5-Whys, Fishbone, and Six Sigma.
• Support NPI with CTQ characteristics and inspection alignment.
• Monitor quality metrics and prepare supplier scorecards and QBRs.
• Lead continuous improvement projects with Six Sigma and Lean.

Skills

Quality Engineering

Auditing

PPAP

Root Cause Analysis

Six Sigma

Gage R&R

Supplier management

Cross-functional collaboration

Education

Bachelor's degree in Mechanical, Electrical, or Industrial Engineering

Lead Auditor Certified ISO 13485 / CQE / CQA or Six Sigma

Tools

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:

• 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.
• 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.
• Direct experience in the Medical Device industry (ISO13485, FDA, EUMDR) required.
• Experience working with Contract Manufacturers/3rd Party Suppliers preferred.

Knowledge, Skills and Abilities:

• 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.

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. Candidate must poses a passport.
• 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.
• Mental Demands: Ability to analyze complex technical and quality data, make sound risk‑based decisions under time‑sensitive conditions, manage multiple priorities, maintain attention to detail, and communicate clearly with cross‑functional teams, suppliers, and leadership in high‑pressure situations.
  #LI-Hybrid
  #LI-LM1

Location:

Orange County

Actual compensation may vary depending on job‑related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

$99,000.00 - $129,000.00

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [e-mail]

About iRhythm Technologies

iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud‑based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.