Quality EngineerJoin a fast-paced medical device manufacturing environment where quality drives innovation. As a Quality Engineer, you will play a key role in bringing new products from concept to commercial production, ensuring compliance, reliability, and manufacturing excellence every step of the way.What You'll DoLead quality activities for new product development (NPD), design transfer, and manufacturing transfer projects.Partner with Engineering, Operations, Supply Chain, and customers to ensure products meet regulatory and quality requirements.Drive process qualification and validation activities (IQ/OQ/PQ) to support successful product launches.Conduct risk assessments using dFMEA, pFMEA, control plans, and other quality tools to identify and mitigate potential issues.Support supplier qualification, process capability studies, and manufacturing readiness initiatives.Utilize statistical methods and data analysis tools to improve processes, reduce defects, and drive continuous improvement.Lead root cause investigations and CAPA activities to resolve quality issues and strengthen product performance.Serve as a trusted quality partner throughout the product lifecycle, communicating project progress, risks, and outcomes to stakeholders.What We're Looking ForBachelor's degree in Engineering or a related technical discipline.5+ years of Quality Engineering experience in medical devices or other regulated manufacturing environments.Strong experience with NPD, design transfer, process validation, and manufacturing transfer.Working knowledge of FDA 21 CFR Part 820, quality systems, and risk management principles.Hands-on expertise with FMEA, DOE, SPC, Gauge R&R, process capability analysis, CAPA, and root cause investigations.Proficiency with statistical software such as Minitab or JMP.Strong project management, communication, and problem-solving skills.Preferred QualificationsExperience in medical device, plating, surface finishing, coatings, or CDMO environments.CQE, Lean Six Sigma, or other quality certifications.Knowledge of cleanroom manufacturing, sterilization processes, software validation, and eQMS systems.Familiarity with Keyence systems, profilometers, and PLC platforms (Allen-Bradley or Siemens).Job Type & LocationThis is a Contract to Hire position based out of Anoka, MN.Pay and BenefitsThe pay range for this position is $45.00 - $58.00/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 & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan – Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in Anoka, MN.Application DeadlineThis position is anticipated to close on Aug 21, 2026.