Quality Engineer

Join 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.

Responsibilities

• Lead 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.

Requirements

• Bachelor'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 Qualifications

• Experience 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).

Schedule

This is a Contract to Hire position based out of Anoka, MN.

Pay

The pay range for this position is $45.00 - $58.00/hr.

Benefits

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 Anoka, MN.