Quality Technician

Job Title:
Quality Technician II (Medical Device)

Duration: 12+ Months (Possible temp to hire)

Onsite Role

1st Shift (6:00AM - 2:30PM)

Responsibilities:

• The primary purpose of the position is to ensure Cardiac Rhythm Management return product complaints are processed, reported and trended timely and accurately.
• The primary responsibility of this role is to investigate returned pacemakers and conduct analyses based on the reported complaint.
• Will collaborate with a broader group of approximately 20 individuals, including an immediate team of about 10.
• 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.
• 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.

Education/

Experience:

• HS diploma/GED is required.
• 1+ year of related experience.
• Proficient in Microsoft Word, Excel, and Outlook
• Solid technical writing skills

Preferred:

• 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