Quality Technician II - Arden Hills, MN

Quality Technician II

We are seeking a Quality Technician II to join the Post Market Complaint Investigation team. In this role, you will investigate returned medical devices to determine what went wrong, identify potential root causes, and document findings that support product quality and continuous improvement efforts.

Working alongside a team of seven technicians, you will perform independent failure analyses, review manufacturing and complaint data, and collaborate with cross-functional teams including Design Quality, R&D, Supplier Management, and Operations to help resolve product issues and improve future product performance.

Key Responsibilities:

• Conduct independent investigations of returned complaint devices to determine failure modes and root causes.
• Perform failure analysis using established testing methods and laboratory equipment.
• Review manufacturing and complaint data to identify trends and support investigations.
• Document investigation results, conclusions, and coding in accordance with quality standards.
• Support investigations related to CAPAs (Corrective and Preventive Actions) and Nonconforming Events (NCEPs).
• Collaborate with cross-functional teams to resolve product quality issues.
• Escalate product concerns when appropriate and contribute to continuous improvement initiatives.
• Support daily laboratory operations and process improvements.

Preferred Qualifications:

• Associate's degree or equivalent related work experience.
• Experience using SAP, MES, or TrackWise.
• 23 years of experience in a manufacturing, production, or quality environment.
• Previous experience in production or manufacturing is highly preferred, as candidates with this background have been successful in the role.

Working Conditions:

• May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.
• The ability to lift up to 30lbs.
• Use of computers and technology.