Description Support the Quality Management System (QMS) organization. Work with design and manufacturing teams, completing operations quality activities. Assignments include use of quality engineering concepts including, but not limited to, 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 applicable 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. - Function as the operation’s quality representative during the execution of engineering projects. - Responsible for ensuring product development projects and changes to existing products are conducted in compliance with the Quality System Regulations. - NCMR and CAPA investigation and reports. including assisting in trouble shooting manufacturing problems and ensuring requirement compliance. Collaborate with suppliers on NCMRs and suppler CAPAs. - Participate in cross-functional teams for the review and disposition of nonconforming products or components. - Participate in cross-functional teams to develop and assist in maintenance of Product Risk Management Files (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 the development of Design Verification and Validation test plans / protocols and Process Verification and Validation test plans / protocols. Provide guidance on Product Requirements compliance. - Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing. - Participate in Design Reviews and FMEA Reviews. - Participate in complaint investigation. Ensure investigations are thoroughly documented. - Provide direction to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods, and design controls), when necessary. - Assist in training of Special Work Orders, Receiving Inspection Processes, and FAIs as required Skills quality engineering, quality systems management, Medical device, Quality management system, process control, risk management, supplier quality, supplier quality assurance, root cause analysis, continuous improvement, Quality assurance, verification software, Test automation, Automated testing, sterilization, failure analysis testing, failure analysis, capa, fda, fda compliance, iso 13485, iso 14971, iso standards Top Skills Details quality engineering,quality systems management,Medical device,Quality management system Additional Skills & Qualifications Requires a B.S. degree in Science, Engineering or Technology or associated fields. 5+ years’ experience in Quality Assurance, including quality systems, standards, metrics, and tools. 5+ years’ experience in the medical device industry. - Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971). - Working knowledge of new product design and development in medical devices. - Working knowledge of the application of risk management, include PFMEA. - Excellent organizational and interpersonal skills working in a cross-functional teams. - Ability to organize and prioritize workflow across multiple projects to meet established time frames and schedules. - Knowledge of manufacturing operations, process verification and validation, and geometric design and tolerance (GD&T) including the ability to read and understand prints and specifications Experience Level Intermediate Level Pay and Benefits The pay range for this position is $38.00 - $48.00/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 Brooklyn Park,MN. Application Deadline This position is anticipated to close on May 2, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.