Manufacturing Quality Engineer - Medical DevicesHelp Ensure Quality in Products That Improve Lives
Join a team dedicated to developing and manufacturing innovative medical devices that make a meaningful impact on patient care. As a Manufacturing Quality Engineer, you'll play a critical role in ensuring products meet quality, safety, and regulatory requirements throughout the product lifecycle.
In this role, you'll partner closely with manufacturing, engineering, operations, and supplier teams to drive product quality, solve complex problems, support regulatory compliance, and continuously improve manufacturing processes. This is an excellent opportunity for a quality professional who enjoys hands-on collaboration, data-driven decision-making, and making a direct impact on product performance and patient safety.
What You'll Do
Serve as the quality representative on manufacturing and product development projects.
Partner with engineering and operations teams to ensure compliance with quality system requirements and regulatory standards.
Lead and support investigations related to nonconforming materials (NCMRs), CAPAs, and manufacturing quality issues.
Perform root cause analysis and implement effective corrective and preventive actions.
Collaborate with suppliers to resolve quality concerns and drive supplier corrective actions.
Support First Article Inspections (FAIs), change order reviews, receiving inspection activities, and other day-to-day quality operations.
Participate in product risk management activities, including PFMEA, DFMEA, risk assessments, and risk management documentation.
Review and approve quality documentation, protocols, reports, and manufacturing records.
Support design verification, validation, process validation, and manufacturing process improvements.
Provide guidance on sampling plans, statistical analysis, and data-driven quality decisions.
Participate in design reviews and cross-functional discussions to ensure quality and risk considerations are addressed early in development.
Support complaint investigations and ensure timely, compliant documentation.
Train and support team members on quality processes, procedures, and inspection requirements.
Drive continuous improvement initiatives that improve product quality, manufacturing efficiency, and compliance.
Required Qualifications
Bachelor's degree in Engineering, Science, Technology, or a related field, or equivalent combination of education and experience.
3+ years of Quality Engineering, Quality Assurance, or Manufacturing Quality experience within a regulated industry.
Experience working within a Quality Management System (QMS).
Experience with CAPA, NCMR, root cause investigations, and corrective action processes.
Knowledge of risk management tools such as PFMEA, DFMEA, and risk assessments.
Experience supporting manufacturing operations and production quality activities.
Understanding of process validation, verification, and quality control methodologies.
Strong analytical, problem-solving, and decision-making skills.
Ability to review technical documentation, engineering drawings, and specifications.
Strong communication skills and the ability to work effectively across cross-functional teams.
Preferred Qualifications
Medical device industry experience.
Experience with catheter-based products, disposable medical devices, or other complex medical technologies.
Knowledge of FDA Quality System Regulations and ISO 13485 requirements.
Experience working in a contract manufacturing, CDMO, or high-volume manufacturing environment.
Experience with supplier quality management and supplier corrective actions.
Knowledge of statistical methods, sampling plans, and data analysis techniques.
Experience supporting verification, validation, sterilization, or manufacturing process qualification activities.
Familiarity with GD&T and interpretation of engineering drawings.
Continuous improvement experience using Lean, Six Sigma, or related methodologies.
Why Join Us?
Work on products that directly impact patient health and outcomes.
Partner with highly skilled engineering, manufacturing, and quality professionals.
Gain exposure to the full medical device product lifecycle, from development through commercialization.
Influence quality systems, manufacturing processes, and continuous improvement initiatives.
Grow your expertise in risk management, regulatory compliance, and product quality within a dynamic environment.
Job Type & Location
This is a Permanent position based out of Maple Grove, MN.
Pay and Benefits
The pay range for this position is $46.00 - $53.00/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 Maple Grove,MN.
Application Deadline
This position is anticipated to close on Jul 31, 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.
