Quality Engineering Senior

Quality Engineer

Reports to: Manager, Manufacturing Quality Engineering

Location: On site Cypress, CA

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.

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.

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.

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.

Lead or support Corrective and Preventive Action (CAPA) investigations and implementation.

• 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.

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
• 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.

Support process validation activities (IQ/OQ/PQ) for manufacturing equipment and processes.

· 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.

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 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)

Experience with Enterprise Resource Planning (ERP) systems (i.e. QAD, SAP)

Experience using electronic Quality Management Systems (eQMS)

Master’s degree in engineering (Mechanical, Biomedical, Electrical, Industrial, or related field)

ASQ Certified Quality Engineer (CQE)

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

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

#iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. 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.

Zio, the heart monitor that changed the game.

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.Please check any communications to be sure they come directly from @irhythmtech.