• Quality Engineer

    Actalent (Minneapolis, MN)


    Quality Engineer

    Job Description

    Support the Quality Management System (QMS) organization by working with design and manufacturing teams to complete operations quality activities. Use quality engineering concepts such as design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement activities. Ensure desired design and product performance requirements are met in compliance with regulatory, customer, and internal requirements. Skills in other technical areas such as verification testing and sterilization validation are desired. Engage in routine daily activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and training.

    Responsibilities

    + Function as the operation’s quality representative during the execution of engineering projects.

    + Ensure product development projects and changes to existing products comply with the Quality System Regulations.

    + Conduct NCMR and CAPA investigation and reporting, assist in troubleshooting manufacturing problems and ensuring requirement compliance.

    + Collaborate with suppliers on NCMRs and supplier CAPAs.

    + Participate in cross-functional teams for the review and disposition of nonconforming products or components.

    + Develop and assist in maintaining Product Risk Management Files, including Risk Management Plan, Risk Assessments, DFMEA, PFMEA, and Risk Management Report.

    + Prepare and review documentation with a high degree of accuracy, completeness, and effectiveness.

    + Participate in developing Design Verification and Validation test plans/protocols and Process Verification and Validation test plans/protocols.

    + Provide guidance on Product Requirements compliance and direction for sample size and statistical analysis of Verification and Validation testing.

    + Participate in Design Reviews and FMEA Reviews.

    + Participate in complaint investigation and ensure investigations are thoroughly completed.

    + Provide direction to project teams on all Quality Policies/Procedures, including verification, validation, statistical methods, and design controls.

    + Assist in training of Special Work Orders, Receiving Inspection Processes, and FAIs.

    Essential Skills

    + 3-5 years of experience in Medical Device (catheter focused), Quality Assurance, and Manufacturing Quality.

    + Proficiency in quality engineering concepts such as root cause analysis, continuous improvement, and quality standards.

    + Knowledge of ISO standards and validation processes.

    + Experience with Supplier Quality and Audits

    Pay and Benefits

    The pay range for this position is $52.00 - $57.00/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 Minneapolis,MN.

     

    Application Deadline

     

    This position is anticipated to close on Oct 17, 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.