Quality Technician II

TALENT Software Services; Arden Hills (MN); On-site; USD 55,000 - 75,000; Full time

Job summary

TALENT Software Services in Arden Hills, MN, is seeking a role to investigate returned pacemakers and perform analyses based on complaints. You will work with a cross-functional team of about 20 people, including an immediate team of about 10. Strong attention to detail is essential.

Under supervision, you will verify complaints, document findings, and support root-cause investigations, ensuring compliance with quality requirements and proper documentation in GCMS Trackwise.

Qualifications

• HS diploma or GED required.
• Associate degree (AA) in Electronics or related field preferred.
• 1+ year of related experience.
• Proficient in Microsoft Word, Excel, and Outlook.
• Strong attention to detail and solid technical writing skills.

Responsibilities

• Maintain compliance with quality requirements and document training as needed.
• Receive and verify returned product complaints; perform initial investigation and root-cause testing; enter information into GCMS complaint database.
• Ensure product traceability for all products received and analyzed.
• Collaborate with cross-functional groups (e.g., R&D and Manufacturing) to obtain information for investigations.
• Follow up with CMC to confirm reported coding accuracy and obtain additional information.
• Prepare and route complaints for approval after complete analysis and documentation.
• Assist in maintaining and updating returned-product test procedures.
• Identify opportunities to improve complaint-handling processes and procedures.
• Maintain lab cleanliness and operate in compliance with procedures and standards.

Skills

Strong attention to detail

Solid technical writing

Education

HS diploma / GED

AA in Electronics

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Oscilloscope

Digital Multimeter

Spectrum Analyzer

Source Meter

Job description

• The primary responsibility of this role is to investigate returned pacemakers and conduct analyses based on the reported complaint. The candidate will collaborate with a broader group of approximately 20 individuals, including an immediate team of about 10. Strong attention to detail is essential.

Description

• The primary responsibility of this role is to investigate returned pacemakers and conduct analyses based on the reported complaint. The candidate will collaborate with a broader group of approximately 20 individuals, including an immediate team of about 10. Strong attention to detail is essential.

Job Purpose

The primary purpose of the position is to ensure Cardiac Rhythm Management return product complaints are processed, reported and trended timely and accurately. Working under close to moderate supervision, incumbent receives general instructions on routine work and detailed instructions on new assignments.

Key Responsibilities

• Maintain compliance with applicable quality requirements, including completing required training and documenting training as needed.
• Receive and verify returned product complaints; perform initial investigation and root-cause testing; and enter complete, accurate information into the GCMS complaint database.
• Ensure product traceability for all products received and analyzed.
• Partner with cross-functional groups (e.g., R&D and Manufacturing) to obtain information needed to complete investigations.
• Follow up with CMC to confirm reported coding is accurate and to obtain additional information when needed.
• Prepare and route complaints for approval after confirming all required analysis and investigation documentation is complete.
• Assist in maintaining and updating returned-product test procedures.
• Identify opportunities and recommend improvements to complaint-handling processes and procedures.
• Maintain lab cleanliness and operate in compliance with corporate procedures and standards.

Qualifications

Required Qualifications

• HS diploma/GED is required.
• Associate degree (AA) in Electronics (or equivalent related experience).
• 1+ year of related experience.
• Proficient in Microsoft Word, Excel, and Outlook
• Strong attention to detail
• Solid technical writing skills

Preferred Qualifications

• Experience working in a regulated quality environment (e.g., complaint handling, investigations, and documentation).
• Experience using complaint management system (e.g. GCMS Trackwise)
• Understanding of basic electrical principles
• Proficiency using electrical test equipment (e.g., oscilloscopes, digital multimeter, power supply, spectrum analyzer, source meter).