Senior Quality Engineer

Intepros; Norwood (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Intepros in Norwood, MA seeks a Senior Quality Engineer to support the effectiveness of our Quality Management System and ensure ISO 13485:2016 compliance. This role collaborates with Quality, Engineering, Operations, and Manufacturing to uphold regulatory standards and drive product quality improvements.

Hands-on quality engineering on the floor includes CAPA, nonconforming material, validation, and root cause investigations.

Qualifications

• 3 to 7 years of quality engineering experience in the medical device or regulated manufacturing sector.
• Strong working knowledge of ISO 13485:2016.
• Experience with CAPA, nonconforming material, root cause analysis, and corrective actions.
• Experience with equipment qualification and process validation (IQ, OQ, PQ).
• FMEA, risk management, First Article Inspection, and MSA familiarity.

Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS).
• Provide hands-on floor support, troubleshoot quality issues, and perform root cause analysis.
• Own CAPA activities, investigations, and effectiveness verification.
• Support equipment qualification and process validation (IQ/OQ/PQ).
• Collaborate with Engineering on validation protocols and testing.
• Manage nonconforming material activities and lead MRB processes.
• Perform First Article Inspections with Quality Control.
• Develop and execute Measurement System Analysis, including Gage R&R where applicable.
• Assist daily operations and CI initiatives to improve KPIs and manufacturing performance.
• Support supplier quality activities and performance feedback.
• Create and revise SOPs, work instructions, and quality documents.
• Provide input into FMEAs and risk management activities.
• Conduct product quality inspections as needed and assist calibration of measurement equipment.
• Deliver quality-related training to employees as needed.

Skills

Quality engineering

CAPA

FMEA

Gage R&R

Root cause analysis

Regulatory compliance

Education

Bachelor's degree in Engineering, Quality, Manufacturing, or related field

Job description

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.