Quality Engineer

For immediate consideration, please email resume to jo! I will be conducting the phone screen for this role!

Quality Engineer

This specialized role requires a focus on regulatory compliance, rigorous testing procedures, and meticulous documentation to ensure that relevant products are safe, effective, and meet all relevant standards before reaching customers.

• Ensure that all testing processes and product developments comply with relevant medical device regulations such as FDA (21 CFR Part 820) and other international standards.
• Maintain thorough and accurate records of all testing procedures, results, and corrective actions to comply with regulatory audit requirements.
• Assist in internal and external audits by regulatory bodies, ensuring all processes meet the necessary compliance standards.
• Conduct risk assessments to identify potential hazards associated with the medical device and develop mitigation strategies.
• Perform Failure Modes and Effects Analysis (FMEA) to systematically evaluate and document potential failure points and their impact on patient safety.
• Identify and document non‑conformances in product quality or processes.
• Conduct root cause analysis for non‑conformances and implement corrective and preventive actions (CAPA) to address and prevent recurrence.
• Work closely with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to ensure product quality throughout the development process.
• Provide training to team members and other departments on quality standards, testing procedures, and regulatory compliance.
• Create and review detailed test protocols that include objective, methods, acceptance criteria, and statistical methods.
• Execute test protocols, including software validation, biocompatibility testing, electrical safety testing, and sterilization validation, depending on the device, component, or assembly.
• Utilize statistical tools and methods to analyze test results, ensuring the reliability and repeatability of the results.

• Proficiency in quality engineering and assurance.
• Experience with audits and quality management systems.
• 5+ years of experience using 5 Whys to identify root cause.
• Experience using 8D for high-impact, systemic, or customer-facing issues.
• Knowledge of GD&T to define, interpret, and verify design intent.
• Experience with statistical analysis and validation processes.
• Familiarity with ISO 9001 standards and supplier quality management.

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 3+ years' experience in validation or quality in a regulated industry.
• Knowledge of FDA and 21 CFR Part 820 standards.
• Certified Quality Engineer (CQE).
• Six Sigma Certifications.
• Lead Auditor certification.

This role offers a 4/10 schedule for production, allowing for longer workdays Monday through Thursday and a half-day on Friday. There is flexibility in start/stop times and the position includes competitive salary and benefits. The work environment fosters solution-oriented partnerships with customers across medical, life sciences, automotive, and other advanced industries. The company is engineering-driven, with over 75 engineers and three decades of manufacturing excellence.

Employees will have the opportunity to receive specialized training in CMM Programming, enhancing job security and marketability.

This is a Permanent position based out of Watertown, CT.

The pay range for this position is $80000.00 - $120000.00/yr.

Company offers a comprehensive healthcare package for employees and eligible dependents:
Medical, dental, and vision insurance;
Health Savings Account (HSA) and Flexible Spending Accounts (FSA);
Life insurance and AD&D coverage;
Short-term and long-term disability insurance;
Employee Assistance Program (EAP) for mental health, counseling, and family support.

This is a fully onsite position in Watertown, CT.

This position is anticipated to close on Feb 26, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.