Senior Quality Engineer

Position Summary

The Senior Quality Engineer is responsible for supporting the effectiveness of the Quality Management System and ensuring compliance with ISO 13485:2016 requirements.

Position Summary

The Senior Quality Engineer is responsible for supporting the effectiveness of the Quality Management System and ensuring compliance with ISO 13485:2016 requirements.

This position partners closely with Quality, Engineering, Operations, and Manufacturing teams to support regulatory compliance, product quality, process improvement, and manufacturing uptime. The role provides hands-on quality engineering support within a production environment and leads key quality processes including CAPA, nonconforming material, validation, and root cause investigations.

Essential Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System, ensuring its ongoing suitability, adequacy, and effectiveness.
• Provide hands-on manufacturing floor support, including troubleshooting, root cause analysis, and resolution of quality-related production issues.
• Own and support Corrective and Preventive Action activities, including investigation, root cause identification, implementation, and effectiveness verification.
• Support equipment qualification and process validation activities, including IQ, OQ, and PQ.
• Partner with Engineering teams to develop and execute validation protocols.
• Manage nonconforming material activities and lead Material Review Board processes where applicable.
• Perform First Article Inspections in partnership with Quality Control personnel.
• Develop and execute Measurement System Analysis activities, including Gage R&R studies, where applicable.
• Support daily operations and continuous improvement initiatives designed to improve key process indicators, product quality, and manufacturing performance.
• Support supplier quality activities, including supplier evaluations, performance reporting, and feedback.
• Create and revise Standard Operating Procedures, Work Instructions, forms, and other controlled quality documentation.
• Provide quality engineering input into FMEAs and other risk management activities.
• Perform product quality inspections as needed.
• Support calibration and monitoring of measurement equipment as needed.
• Provide quality-related training to employees as needed.
• Perform additional quality engineering responsibilities based on business and operational needs.

Qualifications

Experience

• 3 to 7 years of quality engineering experience within the medical device, medical components, or another highly regulated manufacturing environment.
• Strong working knowledge of ISO 13485:2016.
• Experience supporting manufacturing operations and resolving shop-floor quality issues.
• Experience with CAPA, nonconforming material, root cause analysis, and corrective action processes.
• Experience with equipment qualification and process validation, including IQ, OQ, and PQ.
• Familiarity with FMEA, risk management, First Article Inspection, and Measurement System Analysis.

Education

• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field.

Additional Requirements

• Ability to work collaboratively across Quality, Engineering, Operations, and Manufacturing teams.
• Strong documentation, problem-solving, and analytical skills.