Quality Engineer

Quality Engineer – New Product Development & Manufacturing Transfer

Join a fast-paced medical device manufacturing environment where quality drives innovation. As a Quality Engineer, you will play a key role in bringing new products from concept to commercial production, ensuring compliance, reliability, and manufacturing excellence every step of the way.

What You'll Do

• Lead quality activities for new product development (NPD), design transfer, and manufacturing transfer projects.
• Partner with Engineering, Operations, Supply Chain, and customers to ensure products meet regulatory and quality requirements.
• Drive process qualification and validation activities (IQ/OQ/PQ) to support successful product launches.
• Conduct risk assessments using dFMEA, pFMEA, control plans, and other quality tools to identify and mitigate potential issues.
• Support supplier qualification, process capability studies, and manufacturing readiness initiatives.
• Utilize statistical methods and data analysis tools to improve processes, reduce defects, and drive continuous improvement.
• Lead root cause investigations and CAPA activities to resolve quality issues and strengthen product performance.
• Serve as a trusted quality partner throughout the product lifecycle, communicating project progress, risks, and outcomes to stakeholders.

What We're Looking For

• Bachelor's degree in Engineering or a related technical discipline.
• 5 years of Quality Engineering experience in medical devices or other regulated manufacturing environments.
• Strong experience with NPD, design transfer, process validation, and manufacturing transfer.
• Working knowledge of FDA 21 CFR Part 820, quality systems, and risk management principles.
• Hands-on expertise with FMEA, DOE, SPC, Gauge R&R, process capability analysis, CAPA, and root cause investigations.
• Proficiency with statistical software such as Minitab or JMP.
• Strong project management, communication, and problem-solving skills.

Preferred Qualifications

• Experience in medical device, plating, surface finishing, coatings, or CDMO environments.
• CQE, Lean Six Sigma, or other quality certifications.
• Knowledge of cleanroom manufacturing, sterilization processes, software validation, and eQMS systems.
• Familiarity with Keyence systems, profilometers, and PLC platforms (Allen-Bradley or Siemens).

Why Join Us?

• Make a direct impact on innovative medical device products that improve patient outcomes.
• Work on high-visibility NPD and manufacturing transfer projects.
• Collaborate with cross-functional teams in a growing, technology-driven manufacturing environment.
• Gain exposure to advanced manufacturing processes, continuous improvement initiatives, and customer-facing quality leadership opportunities.

This is a Permanent position based out of Anoka, MN.

The pay range for this position is $45.00 - $58.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Anoka,MN.

This position is anticipated to close on Jul 16, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $45 - $58