Quality Engineer

Job Title : Quality Engineer

Job Description

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.

Responsibilities

• 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 objectives, 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.

Essential Skills

Additional Skills & Qualifications

Work Environment

The company fosters product performance by building solution-oriented partnerships with customers and delivering highly technical, measurable outcomes across medical, life sciences, automotive, and other advanced industries. As an engineering company at heart—with over 75 engineers across the organization— they have built a legacy of over three decades of manufacturing excellence. Production works four 10-hour days at this facility, allowing engineering teams the option to work longer days from Monday to Thursday, enabling an early finish on Fridays.

Job Type & Location

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

Pay and Benefits

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

Health & Wellness

Medical Insurance : Multiple plan options, including telehealth services.

Dental & Vision Insurance

Health Savings Account (HSA)

Employee Assistance Program (EAP)

Financial & Retirement

401(k) Plan with employer matching

Charitable Gift Matching

Life Insurance (Company-paid and supplemental options)

Accidental Death & Dismemberment Coverage

Time Off

Paid Holidays

Generous PTO Policy (up to 5 weeks based on tenure)

Unlimited PTO (in some locations or roles)

Sabbatical Leave

Family & Parenting

Maternity & Paternity Leave

Pet Insurance

Professional Development

Live and On-Demand Learning

Leadership Training

Mentorship Matching

Professional Development Budget

Other Perks

Auto / Home Group Insurance Discounts

Accident and Critical Illness Coverage

Inclusive Culture and Social Impact Initiatives

Workplace Type

This is a fully onsite position in Watertown,CT.

Application Deadline

This position is anticipated to close on Dec 17, 2025.