Quality Assurance Engineer

Quality Assurance Engineer – Medical Device Manufacturing (Onsite | Watertown, CT)

Are you ready to take on a hands-on quality leadership role in a highly regulated, fast-paced manufacturing environment? We're looking for a Quality Assurance Engineer to join a global medical device manufacturer known for technical excellence, precision manufacturing, and continuous innovation.

This role offers the opportunity to play a key part in ensuring compliance, quality, and safety across multiple programs supporting advanced medical and life science technologies. If you thrive in an environment where engineering rigor meets real-world impact — this could be the next step in your career.

What You'll Do

• Drive compliance and quality excellence : Ensure all processes meet FDA (21 CFR Part 820), ISO 13485, and global regulatory standards.
• Be audit-ready at all times : Support internal and external audits, ensuring full compliance and documentation integrity.
• Lead risk and failure analysis : Conduct risk assessments, FMEA, and implement effective CAPA strategies to improve process robustness and patient safety.
• Partner across disciplines : Collaborate closely with R&D, Manufacturing, and Regulatory Affairs to ensure quality is built into every stage of product development and production.
• Champion documentation and testing rigor : Develop, execute, and validate test protocols, maintaining thorough records and applying sound statistical analysis.
• Train and influence : Share best practices, conduct quality and compliance training, and build a culture of continuous improvement.

What You Bring

Why You'll Love It