Quality Technician

Position: Quality Technician I
Pay Range: $20-$24/hr. based on experience.

Description:

Hours:

8:00 16:30, with room for flexibility

* Location:

Required 100% onsite in Arden Hills for first 3 months, with potential for 20% remote work, administrative work (1 day a week)

* Interview - 1st round prescreen (phone call/teams) 2nd round teams' interview.

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 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