Quality Technician I

Job Description

Job Summary:

• 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.

Duties and Responsibilities:

• 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 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 medical device industry.