Quality Engineer

Quality Engineer

As a Quality Engineer, you will play a critical role in new product introduction, process validation, and manufacturing transfer activities, partnering with engineering, operations, suppliers, and customers to bring products from development into commercial production.

• Represent Quality on cross-functional product development teams.
• Support design transfer and product commercialization activities.
• Review and approve specifications, validation protocols, engineering changes, and quality documentation.
• Lead or support IQ/OQ/PQ validation activities and process qualification efforts.
• Facilitate manufacturing transfers between sites, suppliers, and customers.
• Drive risk management activities including FMEAs and Control Plans.
• Partner with manufacturing and engineering teams to improve process capability and manufacturing readiness.
• Support supplier qualification, quality investigations, and continuous improvement initiatives.
• Ensure compliance with FDA regulations, quality systems, and applicable industry standards.

• Bachelor's degree in Engineering or related technical discipline.
• 5+ years of Quality Engineering experience within medical device or regulated manufacturing environments.
• Experience with new product introduction, design transfer, process validation, and manufacturing transfers.
• Strong knowledge of FDA regulations, risk management, CAPA, SPC, FMEA, and root cause analysis tools.
• Proficiency with Minitab, JMP, or similar statistical software.
• Excellent communication, analytical, and project management skills.

• Medical device CDMO or contract manufacturing experience.
• CQE, Lean Six Sigma, or related quality certifications.
• Knowledge of cleanroom operations, sterilization processes, and eQMS platforms.
• Experience with DOE, measurement system analysis, and process capability studies.

On-site role within a manufacturing and engineering environment. Occasional travel may be required to customer, supplier, or company locations. Exposure to production and plating areas requires adherence to safety and quality procedures.

Job Type & Location

This is a Permanent position based out of Anoka, MN.

Pay and Benefits

The pay range for this position is $95000.00 - $120000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

PTO, 401K match, and 10 Paid Holidays

Workplace Type

This is a fully onsite position in Anoka, MN.

Final date to receive applications

This position is anticipated to close on Sep 6, 2026.