Sr. Quality Engineer
iRhythm Technologies · Orange County, CA
- Level
- Senior
- Team
- Quality
- Base pay
- $99k–$129k
- Degree
- Required
- Experience asked
- 5+ years
- Certification
- Black Belt preferred
- Industry
- Medical devices
- Posted
- Today
The role in 30 seconds
A senior quality role at iRhythm Technologies (medical devices) in Orange County, CA. Support initiatives to improve manufacturing yield, process stability, and overall product quality performance.
- They ask for
- 5+ years · degree required · Black Belt preferred
- Tools it names
- Six Sigma, Black Belt, Green Belt, Root cause, SPC, CAPA
- Base pay
- $99k–$129k
Read from the posting. The full description is below.
At a glance
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Your game plan for this job
Most people just hit Apply. Do these first and you show up with someone on the inside.
- 1
Find 2–3 people on the Quality team at this site
Engineers who joined in the last year or two reply most.
- 2
Send a short, curious note
Ask about the work, not for a referral. We write it for you.
- 3
Have a 15-minute chat
Good questions for this role:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- The posting mentions a Black Belt. Does the company sponsor certification?
- How did you land the job? What stood out in your interviews?
- 4
Apply, ideally with a referral
Ask if they'd refer you or introduce you to the hiring manager. Send your résumé link and tell them the day you apply.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
About the role
Responsibilities
Manufacturing Quality Support
· Provide daily on-site quality engineering support to manufacturing operations.
· Partner with production teams to ensure product quality, compliance, and efficient resolution of quality issues.
· Participate in Material Review Board (MRB) activities and approve nonconforming product dispositions
· Represent Quality in production escalation and operational review meetings.
Nonconformance & Investigation Leadership
· Lead investigations for nonconformances, deviations, and manufacturing quality issues.
· Apply structured root cause analysis methodologies including: 5 Why, Fishbone, Fault Tree Analysis
· Ensure investigations are data-driven, thorough, and compliant with regulatory expectations.
CAPA Ownership
· Lead or support Corrective and Preventive Action (CAPA) investigations and implementation.
· Ensure robust root cause identification, corrective action effectiveness, and timely closure.
· Collaborate cross-functionally to implement systemic improvements.
Statistical Quality & Data Analysis
· Analyze manufacturing data to identify trends, risks, and opportunities for improvement.
· Utilize Statistical Process Control (SPC) and process capability analysis (Cp/Cpk) to evaluate process performance.
· Support implementation of statistical methods to improve manufacturing robustness.
· Identify opportunities for process capability improvement and defect reduction using statistical methods and structured problem-solving techniques.
Continuous Improvement & Operational Excellence
· Drive continuous improvement initiatives to enhance manufacturing process capability, product quality, and operational efficiency
· Analyze production and quality data to identify systemic issues, trends, and improvement opportunities
· Lead cross-functional problem-solving activities to reduce defects, scrap, rework, and recurring nonconformances
· Partner with Operations and Engineering teams to implement process improvements and mistake-proofing (poka-yoke) solutions.
· Support initiatives to improve manufacturing yield, process stability, and overall product quality performance.
· Monitor and report quality metrics and process performance indicators to drive data-informed decision making.
Process Validation Support
· Support process validation activities (IQ/OQ/PQ) for manufacturing equipment and processes.
· Review and approve validation protocols and reports.
· Ensure validation documentation meets regulatory and internal quality requirements.
Change Control & Risk Management
· Review and support Engineering Change Orders (ECO) to ensure appropriate quality and regulatory impact assessment
· Ensure risk management activities align with ISO 14971 requirements.
· Provide quality input during manufacturing and process changes
Quality Systems Compliance
· Ensure manufacturing quality processes align with 21 CFR 820, FDA QMSR, ISO 13485
· Support internal audits, regulatory inspections, and compliance initiatives as needed.
Education
Bachelor’s degree in engineering (Mechanical, Biomedical, Electrical, Industrial)
Experience
5 years of Quality Engineering experience in a regulated industry
Experience in the medical device industry required
Strong understanding of FDA-regulated manufacturing environments
Quality System Expertise: Demonstrated experience with: CAPA, Nonconformance management, Change control processes, Risk management (ISO14971), Process validation (IQ/OQ/PQ), Statistical Process Control (SPC) and process capability analysis
Regulatory Knowledge: Working knowledge of 21 CFR 820, ISO 13485, and FDA QMSR (Quality Management System Regulation)
Systems Experience: Experience with Enterprise Resource Planning (ERP) systems (i.e. QAD, SAP)
Experience supporting electromechanical or wearable medical devices
Familiarity with Design of Experiments (DOE) and statistical software such as Minitab
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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
Position: Sr. Quality Engineer
Reports to: Manager, Manufacturing Quality Engineering
Location: On site Cypress, CA
About this role
The Senior Quality Engineer provides on-site quality engineering support for high-volume manufacturing operations of regulated medical devices. This role partners closely with Engineering and Operations to ensure product quality, regulatory compliance, and continuous improvement of manufacturing processes.
The Sr. Quality Engineer leads manufacturing quality investigations, supports manufacturing quality systems, and drives corrective and preventive actions (CAPA) in compliance with FDA Quality System Regulation (21 CFR 820), the FDA Quality Management System Regulation (QMSR), ISO 13485, and internal quality standards. This position plays a key role in ensuring that manufacturing processes operate with the highest standards of quality, compliance, and operational excellence.
Preferred Skills
Master’s degree in engineering (Mechanical, Biomedical, Electrical, Industrial, or related field)
ASQ Certified Quality Engineer (CQE)
Six Sigma Green Belt or Black Belt
ISO 13485 Lead Auditor certification
Key Competencies
Strong analytical and problem-solving skills
Ability to lead complex root cause inves