Job Summary: Talent Software Services is in search of a Quality Technician for a contract position in Arden Hill, MN. The opportunity will be for one year with a strong chance for a long-term extension.
Position Summary: Provide Quality Technician support to the 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.
Primary Responsibilities/Accountabilities:
Assist 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.
Interpret test results and device analysis and examine for unusual characteristics.
Write investigation reports, summarizing findings from the performed device analysis, and clearly state conclusions that can be drawn from those findings.
Troubleshoot procedures that may have been compromised, thus determining the potential cause of unexpected results of routine tests.
Communicate with customers and appropriate technical staff regarding testing schedule information, results, or unanticipated discoveries.
Analyze, review, and document the status of lab records for archiving.
Administer the flow of test requests, from logging in through filing and archiving.
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:
Associate Degree in a technical discipline.
Electrical and mechanical equipment experience preferred.
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.
If this job is a match for your background, we would be honored to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!
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