Quality Technician II

Pacemaker Investigation Specialist

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.

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).