Job Description

Job Title: Quality Assurance Engineer Job Description The Quality Assurance Engineer is responsible for developing new processes and products, validating new equipment and technology, and assisting production with continuous improvement on the shop floor. This role involves managing customer complaints, handling CAPA/NCR activities, leading change requests with customers, and ensuring compliance with ISO, FDA, and other applicable standards. The Quality Engineer collaborates closely with QA Technicians and Quality Inspectors. Responsibilities + Develop new processes and products and revise existing ones. + Create and update project-specific quality plans, ensuring adherence to customer requirements. + Work as part of a cross-functional team. + Develop methods to measure products to ensure they meet quality standards. + Troubleshoot measurement methods and equipment to ensure accuracy and reliability. + Lead validation of new products and technology (IQ, OQ, PQ). + Act as QA lead for equipment validation. + Collaborate with customers and suppliers on new product processes. + Lead customer complaints and supplier SCAR management. + Compile and analyze statistical data to assess process capabilities. + Conduct PFMEA, GR&R, and SPC studies. + Create and maintain quality system documentation, including quality plans, inspection and control plans, and work instructions. + Manage NCR, CAPA, and customer complaints from creation to closure. + Use problem-solving tools and work as part of a cross-functional team. + Lead changes in production, ensuring compliance with customer agreements, ISO standards, and internal requirements. + Prepare, submit, and follow change requests (SCR) with customers. + Assist production in achieving APU objectives. + Generate quality KPIs for PSM2. + Perform internal and external audits. + Serve as backup for other QEs on customer or internal tasks as requested by the QA manager. + Identify and support continuous improvement opportunities and participate in LEAP workshops. Essential Skills + Quality assurance + Process improvement + Validation verification + Metrology experience + GD&T + Experience with CNC machines + Continuous improvement + CAPA + Non-conforming management + ISO compliance + Manufacturing engineering + Quality engineering + Root cause analysis + Manufacturing process + Supplier quality + Quality control + Audit + Medical device troubleshooting + 2+ years of relevant experience Additional Skills & Qualifications + Experience in statistical analysis + Experience conducting PFMEA, GR&R, and SPC studies Job Type & Location This is a Permanent position based out of Minneapolis, MN. Pay and Benefits The pay range for this position is $80000.00 - $95000.00/yr. Competitive Benefits Include:- Medical, dental, vision, life insurance, paid time off and 401K.- Tuition reimbursement to support your development; floating holidays that you take for days that are important to you. Workplace Type This is a fully onsite position in Minneapolis,MN. Application Deadline This position is anticipated to close on Nov 14, 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.

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