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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

+ Quality engineering

+ Quality assurance

+ Audit

+ Medical device knowledge

+ CMM Programming

+ GD&T

+ Root cause analysis

+ PPAP

+ Quality management system

+ Corrective action plans

+ PFMEA

Additional Skills & Qualifications

+ Bachelor’s in Engineering, Life Sciences, or related field.

+ 3+ years' experience in validation or quality in a regulated industry.

+ Knowledge of FDA and 21 CFR Part 820 standards.

Work Environment

They improve product performance by building solution-oriented partnerships with our customers and delivering highly technical, measurable outcomes across medical, life sciences, automotive, and other advanced industries. They are an engineering company at heart—with over 75 engineers across the organization—and have built a legacy of over three decades of manufacturing excellence by doing what others consider impossible. Production works 4/10s at this facility so engineering can elect to work longer days Monday through Thursday to get out early on Fridays.

Job Type & Location

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

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 InsuranceHealth Savings Account (HSA)Employee Assistance Program (EAP)

Financial & Retirement

401(k) Plan with employer matchingCharitable Gift MatchingLife Insurance (Company-paid and supplemental options)Accidental Death & Dismemberment Coverage

Time Off

Paid HolidaysGenerous PTO Policy (up to 5 weeks based on tenure)Unlimited PTO (in some locations or roles)Sabbatical Leave

Family & Parenting

Maternity & Paternity LeavePet Insurance

Professional Development

Live and On-Demand LearningLeadership TrainingMentorship MatchingProfessional Development Budget

Other Perks

Auto/Home Group Insurance DiscountsAccident and Critical Illness CoverageInclusive 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 Nov 4, 2025.

About Actalent

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 [email protected] (%[email protected]) for other accommodation options.