Quality Technician II

Job Description

Job Summary:

• 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.

Duties and 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 Client 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.

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., Oscillo Products, digital multimeter, power supply, spectrum analyzer, source meter).