Quality Technician I

Quality Technician

About the role: Provide Quality Technician support to Arden Hills Post-Market Complaint Investigation Lab, ensuring delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives. This is a dynamic support role in the Electrophysiology division requiring cross-functional collaboration with Returns Processing, Dock Shipping & Receiving, and Quality team members. This role is responsible for the analysis of non-return complaints, WIP intake & organization, returned device tracking, shipments of returned product, and documentation within quality system.

Your responsibilities will include:

• Analyze non-returned medical device complaints, with engineering support, to determine the likely cause of reported allegations
• Review device history records (DHR), product labeling, and risk documentation to support complaint investigations
• Perform intake, organize, and maintain order of returned medical device complaint WIP by assessing reported allegations, relevance, and urgency to support analysis prioritization
• Track the status and physical location of returned complaint devices throughout the investigation process, ensuring accurate documentation and traceability at all stages
• Coordinate shipments of returned products to internal sites and external suppliers
• Order and maintain inventory of general laboratory supplies
• Maintain laboratory organization and cleanliness in alignment with 5S principles to ensure an efficient and compliant lab environment
• Manage archival storage of completed complaint investigations, including sorting devices and arranging for appropriate disposition/disposal
• Prioritize individual tasks efficiently to meet deadlines and provide deliverables while adhering to internal metrics and timelines
• Perform hands-on analysis of returned medical device complaints, as needed, to support root cause determination and investigation activities
• Write investigation reports, summarizing findings from the performed device analysis, and clearly state conclusions that can be drawn from those findings

Required qualifications:

• High School Degree or GED
• 1 year of related work experience
• Must work well in a team environment
• Proficient with Microsoft Office tools, including Word, Excel, PowerPoint, and Outlook
• Good oral and written communication skills
• Strong organizational skills with excellent attention to detail

Preferred qualifications:

• Associate degree (or equivalent related work experience) in a technical discipline
• Self-starter with the ability to identify improvement opportunities
• Able to work independently under limited supervision as well as in a team environment
• Able to read, understand, and communicate procedural requirements
• 1 year of quality or manufacturing experience in the medical device industry