A leading recruitment agency is seeking a Design Quality Engineer in Hudson, Massachusetts. The role focuses on leading design assurance for new product development, ensuring compliance with FDA and ISO standards. The ideal candidate has a B.S. in engineering, 5+ years of experience in quality management within the medical device sector, and strong skills in risk management and documentation. This position offers a competitive salary, career growth opportunities, and a supportive environment.
Qualifications
5+ years of quality management experience in medical devices or life sciences.
Strong knowledge of design quality and regulatory standards.
Experience with risk assessment and management in engineering and manufacturing processes.
Responsibilities
Ensure compliance with regulatory and quality standards during the design and development process.
Collaborate with cross‑functional teams to identify and resolve design‑related quality issues.
Conduct risk assessments and implement effective risk management strategies.
Support validation and verification activities for new products.
Analyze quality data to identify trends and implement corrective actions.
Skills
Quality engineering
Medical device regulations
Risk management
Documentation
Cross-functional communication
Education
B.S. in a science or engineering field
Job description
A leading recruitment agency is seeking a Design Quality Engineer in Hudson, Massachusetts. The role focuses on leading design assurance for new product development, ensuring compliance with FDA and ISO standards. The ideal candidate has a B.S. in engineering, 5+ years of experience in quality management within the medical device sector, and strong skills in risk management and documentation. This position offers a competitive salary, career growth opportunities, and a supportive environment.