Our client, a leading Medical Device / Life Sciences company, is hiring a Design Assurance Quality Engineer.

Work Location: Middlesex County, Massachusetts

Summary:

Provide quality engineering support across product development projects from concept through launch with emphasis on design controls and regulatory compliance. Work collaboratively with R&D, Manufacturing, Sales & Marketing, and cross-functional teams to ensure quality and compliance within the Quality Management System (QMS).

Responsibilities:

• Serve in a Design Assurance (DA) role on product development projects.
• Lead cross-functional teams in risk assessment and risk management processes, including FMEAs and associated risk documentation.
• Support the development, implementation, and maintenance of Design Verification & Validation (V&V) methodologies and best practices to ensure product quality and timely launches.
• Interface with manufacturing, NPI engineering, R&D, and quality team members to ensure effective design transfer to manufacturing.
• Participate in post-market surveillance activities as part of continuous improvement and quality compliance.

Qualifications:

• Bachelor’s degree in a related technical field (preferably Engineering).
• 3-5 years of design assurance experience in the life sciences or medical device industry.
• Working knowledge of 21 CFR 820 (FDA Quality System Regulation) and ISO 14971:2019 (risk management).
• Familiarity with data analysis methods and basic statistics (e.g., using Minitab or similar tools).
• Strong teamwork, flexibility, adaptability to change, communication, and organizational skills.
• Ability to lead through influence and contribute independently to quality activities.

Published Category: Quality & Validation