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. Skills Medical device, Quality assurance, quality management system, Design assurance, Quality engineering, New product development, Design control, Design, Solidworks, Root cause analysis, Process development, R&d, iso 13485, quality system, risk management, pfmea, process validation, gd&t, Capa Additional Skills & Qualifications - 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. Pay and Benefits The pay range for this position is $53.00 - $60.00/hr. Workplace Type This is a fully onsite position in Minneapolis,MN. 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.