Sr. Quality Engineer

iRhythm Technologies, Inc.; Anaheim (CA); On-site; USD 99,000 - 129,000; Full time

Job summary

iRhythm Technologies, Inc. is seeking a Sr. Quality Engineer for on-site support in Cypress, CA. You will lead quality investigations, CAPA activities, and data-driven improvements across high-volume manufacturing of regulated medical devices.

The role requires 5 years of quality engineering in regulated environments, familiarity with FDA/QMSR standards, and ERP/eQMS experience to enhance product quality and compliance.

Qualifications

• Bachelor's degree in engineering (Mechanical, Biomedical, Electrical, Industrial).
• 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: CAPA, Nonconformance, Change control, Risk management (ISO14971), IQ/OQ/PQ, SPC and CP/CPk.
• Regulatory Knowledge: 21 CFR 820, ISO 13485, FDA QMSR.

Responsibilities

• Manufacturing Quality Support: on-site quality engineering for manufacturing operations.
• Nonconformance & Investigation Leadership: lead investigations and ensure data-driven findings.
• CAPA Ownership: investigate and implement corrective and preventive actions.
• Statistical Quality & Data Analysis: analyze data using SPC and Cp/Cpk.
• Continuous Improvement: drive process improvements and defect reduction.
• Process Validation Support: assist IQ/OQ/PQ for equipment and processes.
• Change Control & Risk Management: review ECOs and ensure ISO14971 alignment.
• Quality Systems Compliance: ensure compliance with 21 CFR 820, QMSR, ISO 13485.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

Education

Bachelor's degree in engineering

Tools

QAD

SAP

eQMS

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

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
• Nonconformance & Investigation Leadership
• CAPA Ownership
• Statistical Quality & Data Analysis
• Continuous Improvement & Operational Excellence
• Process Validation Support
• Change Control & Risk Management
• Quality Systems Compliance

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 #LI-onsite

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.