Quality Technician II Location:

Arden Hills, MN Position Type:

Full-Time Contract Work Arrangement:

Onsite Job Summary The Quality Assurance Technician plays a critical role in post-market surveillance by conducting root-cause analysis and electrical failure testing on returned Cardiac Rhythm Management (CRM) devices, specifically pacemakers. Operating within a regulated quality environment, this position is responsible for ensuring returned product complaints are accurately investigated, processed, and documented in accordance with FDA and international regulatory standards.

Key Responsibilities Product Investigation & Failure Analysis:

Perform initial physical inspection, electrical testing, and root-cause analysis on returned pacemakers using specialized lab equipment.

Database & Compliance Management:

Input detailed, precise data into the Global Complaint Management System (GCMS) and maintain end-to-end product traceability for all analyzed devices.

Cross-Functional Collaboration:

Partner with R&D, Manufacturing, and Customer Management Center (CMC) teams to verify reported complaint codes, gather supplemental technical data, and complete multi-disciplinary investigations.

Quality Documentation:

Prepare, review, and route technical investigation reports for final approval, ensuring alignment with corporate quality management systems (QMS) and regulatory requirements.

Process Improvement & Lab Upkeep:

Maintain test equipment, support the continuous improvement of returned-product test procedures, and adhere to laboratory safety and cleanliness protocols. Qualifications High School Diploma or GED required. Associate Degree (A.A.) in Electronics (or equivalent related hands-on experience). 1+ years of related experience in electronics testing, troubleshooting, or quality processing. Proficiency in Microsoft Office suite (Word, Excel, Outlook). Strong attention to detail and solid technical writing capabilities. Preferred Qualifications Prior experience working in a regulated quality environment (e.g., medical device complaint handling, failure investigations, and regulatory documentation). Hands-on experience using complaint management databases (e.g., GCMS, TrackWise). Solid understanding of basic electrical principles and circuits. Proficiency using electrical test equipment (e.g., Oscilloscopes, Digital Multimeters, Power Supplies, Spectrum Analyzers, Source Meters).

Pay:

Up to $26.00 per hour

Experience:

Electronics Testing:

1 year (Required) Ability to

Commute:

Arden Hills, MN 55126 (Required)

Work Location:

In person