Quality Engineer

Job Title:

Quality Engineer-Medical Device

Location:

Minneapolis, MN Duration: 12 Months

Job Summary:

We are seeking a Quality Engineer to support remediation and process validation activities in a medical device manufacturing environment
. The role involves working closely with manufacturing teams to investigate quality issues, implement corrective actions, and support validation activities.

• Work on the production floor with process owners to review and improve manufacturing processes
• Investigate non-conformance events (NCEs) and perform root cause analysis
• Develop and implement CAPA and ensure corrective actions are effective
• Manage and resolve Non-Conformance Reports (NCRs)
• Support process validation activities (TMV, OQ, PQ)
• Collaborate with Manufacturing Engineering and Production teams
• Track remediation progress and share updates with stakeholders
• Ensure compliance with quality systems and regulatory requirements

• Experience in Quality Engineering within medical device manufacturing
• Strong knowledge of CAPA, NCR/NCE investigations, and root cause analysis
• Experience with process validation (TMV, OQ, PQ)
• Ability to work cross-functionally with manufacturing and engineering teams.