Sr. Quality Engineer

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.

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.

Required Qualifications:

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 using electronic Quality Management Systems (eQMS)

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

Experience in high-volume manufacturing environments

Experience supporting electromechanical or wearable medical devices

Familiarity with Design of Experiments (DOE) and statistical software such as Minitab

Key Competencies:

Strong analytical and problem-solving skills

Ability to lead complex root cause investigations

Data-driven decision making

Cross-functional collaboration with operations and engineering teams

Strong understanding of manufacturing quality systems

Ability to balance operational urgency with regulatory compliance

#LI-AM1
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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 [email protected]

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.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121