Job Description

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

• Bachelor’s degree in Engineering, Life Sciences, or related field .
• 3+ years of experience in a regulated manufacturing environment (medical device preferred).
• Deep understanding of FDA, ISO 13485, and 21 CFR Part 820 standards.
• Hands-on experience with root cause analysis, CAPA, FMEA, validation, and data-driven problem-solving .
• Proficiency with tools such as Minitab, Excel, Power BI, SolidWorks, or ERP/QMS platforms .
• Professional certifications such as CQE, Six Sigma, or ISO 13485 Lead Auditor are highly valued.

Why You’ll Love It

• A culture that values technical excellence, precision, and problem-solving .
• The opportunity to work with cutting-edge medical technologies that directly improve lives.
• A mix of hands-on work and strategic quality leadership — ideal for someone who wants both responsibility and visibility.
• Competitive compensation, strong mentorship, and the chance to grow within a leading medical manufacturing organization.

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