Quality Technician II

Job Description

Job Summary:

• 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.

Duties and Responsibilities:

• 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 cross‐functional 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 complaint‐handling workflows.
• Maintain laboratory cleanliness and operate in compliance with corporate standards and procedures.

Required Qualifications:

• 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.

Preferred Qualifications:

• 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 oscillo Products, digital multimeters, power supplies, spectrum analyzers, and source meters.

Interview Process:

• Onsite interviews.
• Two interview rounds.
• Each interview will be 30–45 minutes.
• Candidates will meet with 1–2 interviewers per round.