Validation / Operations Quality Engineer Medical Devices

Help bring life-changing medical technologies to market. We are seeking a Validation / Operations Quality Engineer to support manufacturing, process validation, and quality system activities in a fast-paced, FDA-regulated medical device environment. This role partners closely with Operations, Manufacturing Engineering, R&D, and Supply Chain to ensure products and processes meet the highest standards of quality, compliance, and performance.

What You'll Do

• Lead and execute validation activities, including IQ/OQ/PQ, Process Validation, Test Method Validation (TMV), Equipment Qualification, and Software Validation support.
• Develop validation protocols, reports, and supporting documentation.
• Support manufacturing transfers, line qualifications, and process improvements.
• Troubleshoot manufacturing and process issues to improve quality, yield, and efficiency.
• Analyze process and quality data using statistical methods.
• Lead and support nonconformance investigations, root cause analysis, and CAPA activities.
• Review manufacturing documentation, procedures, DHRs, and engineering changes.
• Support internal, customer, FDA, and ISO audits and inspections.
• Ensure compliance with FDA Quality System Regulations, ISO 13485, and other applicable requirements.
• Collaborate cross-functionally to drive continuous improvement initiatives.

What We're Looking For

• Bachelor's degree in Engineering or a related technical field.
• 3+ years of Quality Engineering and/or Validation experience within the medical device industry.
• Experience authoring and executing validation protocols and reports.
• Strong understanding of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, CAPA systems, nonconformance investigations, and root cause analysis methodologies.
• Experience supporting manufacturing operations in a regulated environment.
• Strong technical writing, documentation, and problem-solving skills.

Preferred Qualifications

• Experience in a startup or small medical device company.
• Hands-on experience with process validation, TMV, and equipment qualification.
• Proficiency with statistical analysis tools such as Minitab.
• Lean Manufacturing and/or Six Sigma experience.
• Experience with Class II/III medical devices, implants, electrophysiology, or disposable medical products.

Why Join Us?

• Make a direct impact on patient care through innovative medical technologies.
• Work cross-functionally with engineering, operations, and quality leaders.
• Drive meaningful process improvements in a highly regulated environment.
• Join a collaborative team that values quality, innovation, and continuous learning.
• Gain exposure to manufacturing, validation, compliance, and new product development activities.
• If you are passionate about quality, validation, and solving complex manufacturing challenges in the medical device industry, we encourage you to apply.

Job Type & Location

This is a Permanent position based out of Saint Paul, MN.

Pay and Benefits

The pay range for this position is $45.00 - $60.00/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).

Workplace Type

This is a fully onsite position in Saint Paul, MN.

Application Deadline

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.