Sr. Quality Engineer

iRhythm • Orange County, CA

17d • Onsite

About The Position

The Senior Quality Engineer provides on-site quality engineering support for high-volume manufacturing operations of regulated medical devices. The role partners closely with Engineering and Operations to ensure product quality, regulatory compliance, and continuous improvement of manufacturing processes. The Senior Quality Engineer leads manufacturing quality investigations, supports manufacturing quality systems, and drives corrective and preventive actions in compliance with FDA Quality System Regulation (21 CFR 820), FDA Quality Management System Regulation (QMSR), ISO 13485, and internal quality standards. The position helps ensure manufacturing processes meet high standards of quality, compliance, and operational excellence.

Requirements

• Bachelor’s degree in engineering (Mechanical, Biomedical, Electrical, or Industrial).
• At least 5 years of Quality Engineering experience in a regulated industry.
• Medical device industry experience is required.
• Strong understanding of FDA-regulated manufacturing environments.
• Demonstrated experience with CAPA, nonconformance management, change control processes, risk management (ISO 14971), process validation (IQ/OQ/PQ), SPC, and process capability analysis.
• Working knowledge of 21 CFR 820, ISO 13485, and FDA QMSR.
• Experience with ERP systems such as QAD or SAP.
• Experience using electronic Quality Management Systems (eQMS).
• 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.

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.

Responsibilities

• Provide daily on-site quality engineering support to manufacturing operations and partner with production teams to resolve 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 using structured root cause analysis methods, including 5 Why, Fishbone, and Fault Tree Analysis.
• Ensure investigations are data-driven, thorough, and compliant with regulatory expectations.
• Lead or support CAPA investigations and implementation, ensuring robust root cause identification, corrective action effectiveness, and timely closure.
• Collaborate cross-functionally to implement systemic improvements.
• Analyze manufacturing data to identify trends, risks, and improvement opportunities; use SPC and process capability analysis (Cp/Cpk) to evaluate process performance.
• Support implementation of statistical methods to improve manufacturing robustness and identify opportunities for process capability improvement and defect reduction.
• Drive continuous improvement initiatives to enhance manufacturing process capability, product quality, and operational efficiency.
• Lead cross-functional problem-solving activities to reduce defects, scrap, rework, and recurring nonconformances.
• Partner with Operations and Engineering to implement process improvements and mistake-proofing (poka-yoke) solutions.
• Support improvements to manufacturing yield, process stability, and product quality performance; monitor and report quality metrics and process performance indicators.
• 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.
• Review and support Engineering Change Orders (ECOs), including quality and regulatory impact assessment.
• Ensure risk management activities align with ISO 14971 and provide quality input during manufacturing and process changes.
• Ensure manufacturing quality processes align with 21 CFR 820, FDA QMSR, and ISO 13485.
• Support internal audits, regulatory inspections, and compliance initiatives as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior