Sr. Quality Engineer

About the role

Position: Sr. Quality Engineer
Reports to: Manager, Manufacturing Quality Engineering
Location: On site, Cypress, CA (Orange County)

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

Requirements

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 (ISO 14971), 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 qualifications

• 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

Pay

Estimated Pay Range: $99,000.00 - $129,000.00 (actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location)