Quality Technician II

Job Description
Quality Technician II
Arden Hills, MN- Onsite
Duration: 12 Months+ Possible extension
Pay Rate: $20-$29/hr.
1st Shift (06:00:AM - 02:30:PM)

• Onsite interviews
• Two interview rounds
• Each interview will be 3045 minutes
• Candidates will meet with 12 interviewers per round

The primary responsibility of this role is to investigate returned pacemakers and conduct detailed analyses based on reported product complaints. The individual will collaborate with a broader group of approximately 20 team members, including an immediate team of about 10 colleagues. Strong attention to detail and the ability to work within a regulated quality environment are essential for success in this role.

The purpose of this position is to ensure that Cardiac Rhythm Management (CRM) returned product complaints are processed, reported, and trended accurately and in a timely manner. Working under close to moderate supervision, the incumbent will receive general instructions for routine tasks and detailed guidance for new or complex assignments.

• Maintain compliance with applicable quality and regulatory requirements, including completing and documenting required training.
• Receive and verify returned product complaints.
• Perform initial investigations and root cause testing.
• Enter complete and accurate investigation data into the GCMS complaint database.
• Ensure full product traceability for all received and analyzed devices.
• Partner with crossfunctional teams (e.g., R&D and Manufacturing) to obtain necessary information for investigations.
• Follow up with CMC to confirm accurate complaint coding and gather additional information as needed.
• Prepare and route complaint reports for approval once all required documentation is complete.
• Assist in maintaining and updating returned product testing procedures.
• Identify opportunities for process improvements within complainthandling workflows.
• Maintain laboratory cleanliness and operate in compliance with corporate standards and procedures.

• Associate degree (AA) in Electronics or equivalent relevant experience.
• Minimum of 1 year of related experience.
• Proficiency in Microsoft Word, Excel, and Outlook.
• Strong attention to detail.
• Solid technical writing skills.

• Experience working in a regulated quality environment (e.g., complaint handling, product investigations, documentation).
• Experience using complaint management systems (e.g., GCMS, TrackWise).
• Understanding of basic electrical principles.
• Proficiency with electrical test equipment such as oscilloProducts, digital multimeters, power supplies, spectrum analyzers, and source meters.