What are the responsibilities and job description for the Quality Engineer position at Actalent?
For immediate consideration, please email resume to jonukwugha@actalentservices.com! I will be conducting phone screens for this role this week and next week!
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 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 Nov 7, 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 actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $80,000 - $120,000