Job Description

Senior Manufacturing Quality Engineer - $100k-$135k

Burlington, MA

US Citizen or Green Card Holders only

Our client is looking for an experienced Quality Engineer to join their team and support Manufacturing Engineering and Production Sustaining efforts in a dynamic medical device manufacturing environment. In this collaborative role, you'll work closely with Operations, R&D, and other teams to ensure compliance with the Quality Management System (QMS).

Are you a seasoned Quality Engineer who thrives at the Operations end of Design Transfer? Do you excel at handling daily manufacturing challenges, leading yield improvement initiatives, and driving successful scale-up projects?

Key Responsibilities:

• Ensure quality system implementation and oversight within manufacturing processes.
• Provide Design Assurance Engineering and support during Product Development or post-market changes.
• Collaborate cross-functionally to drive process improvements using Quality Systems.
• Ensure product specifications are met and required documentation is complete.
• Support verification and validation activities, including protocol/report development and test method validation.
• Lead risk management activities such as hazard analysis and FMEA.
• Assist in developing and implementing key quality functions across the organization.
• Build and maintain relationships with internal teams and suppliers.
• Participate in product development, design reviews, and change control teams.
• Conduct risk analysis on new designs and processes.
• Support calibration systems, equipment qualification, and preventive maintenance.
• Assist with raw material/component inspections and non-conformance investigations.
• Ensure supplier compliance with regulatory standards.
• Provide support for production control, test method validations, and Gauge R&R.
• Conduct internal audits and support CAPA processes.
• Participate in third-party audits and inspections.
• Assist with management reviews and provide reports as needed.

Qualifications:

• Bachelor’s degree in engineering or related field.
• 5+ years of experience as a Quality Engineer in the medical device industry, with a focus on manufacturing quality.
• Experience in design transfer, yield improvement, and scale-up projects.
• Proficient in writing protocols, evaluating testing results, and conducting product/process validation.
• Strong knowledge of QMS and regulatory compliance (domestic/international).
• Excellent communication skills, with the ability to collaborate at all levels.
• Solid understanding of manufacturing quality control, troubleshooting, and process improvements.

Why Apply? If you have a passion for quality engineering and a background in medical device manufacturing, our client needs you. Be part of a dynamic organization where your expertise will directly contribute to the success of new products and improvements across the manufacturing process.

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