Sr. Quality Engineer

iRhythm•Orange County, CA

24d•$99,000 - $129,000•Onsite

About The Position

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.

Requirements

Bachelor’s degree in engineering (Mechanical, Biomedical, Electrical, Industrial, or related discipline)
5 years of Quality Engineering experience in a regulated industry
Experience in the medical device industry Strongly Preferred with a 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)

Nice To Haves

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
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
Location: Orange County

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.