Title: Quality Technician - Complaint Investigation

Location: Arden Hills, MN

Duration: 12-month contract on W2 with a high possibility of extension based on performance.

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 R&D, Design Assurance, Manufacturing, and Quality team members. This role is responsible for the hands-on investigation and analysis of returned device failures, responding to quality signals, and documenting findings inside the quality system.
• Assists engineering in providing quality support by learning to analyze data and identify complaint issues and trends.
• Perform device analysis on returned medical devices, with engineering support, to determine the likely cause of device malfunction.
• Review device history records (DHR), product labeling and risk documentation to support complaint investigation.
• Prioritize individual tasks efficiently to meet deadlines and provide deliverables while adhering to internal metrics and timelines.
• Interprets test results and device analysis and examines for unusual characteristics.
• Write investigation reports, summarizing findings from the performed device analysis, and clearly state conclusions that can be drawn from those findings.
• Troubleshoots procedures that may have been compromised, thus determining the potential cause of unexpected results of routine tests.
• Communicates with customers and appropriate technical staff regarding testing schedule information, results, or unanticipated discoveries.
• Analyzes, reviews, and documents the status of lab records for archiving.
• Administers the flow of test requests, from logging in through filing and archiving.

Required qualifications:

• Associate degree (or equivalent 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.

Preferred qualifications:

• Electrical and mechanical equipment experience preferred.
• 1 year of quality or manufacturing experience in medical device industry