Quality Technician II

Job Description

Job Summary:

• Support the Complaint Investigation Services (CIS) Laboratory by performing technical investigations of returned medical device complaints, documenting results, and supporting complaint handling activities in a compliant and timely manner.
• This position may also support decontamination operations, laboratory activities, and quality improvement initiatives based on business needs.

Responsibilities:

• Perform investigations, testing, and analysis of returned complaint products.
• Document findings and investigation results in applicable quality systems.
• Ensure product traceability and proper handling of returned products.
• Collaborate with Manufacturing, R&D, Quality, and Regulatory teams to support investigations.
• Support complaint trending, and risk reviews as needed.
• Maintain laboratory equipment, calibration records, and work areas.
• Assist with updates to procedures, work instructions, and process improvements.
• Maintain compliance with quality system, safety, and training requirements.
• Support product decontamination activities, including handling, processing, and documentation of returned products as required.

Required Qualifications:

• Associate degree in a technical or scientific field, or equivalent combination of education and experience.
• Minimum 1 year of experience in Quality, Manufacturing, Laboratory Operations, Medical Devices, or a related field.
• Strong troubleshooting, documentation, and organizational skills.
• Ability to work independently in a regulated environment.

Preferred Qualifications:

• Experience with complaint investigations, failure analysis, or laboratory testing.
• Knowledge of medical device quality systems and complaint handling processes.
• Experience with product decontamination, biohazard handling, or returned product processing.
• Educational background or hands-on experience in Electronics Technology and Mechanical Technology or related technical disciplines.
• Experience troubleshooting electromechanical or medical device products preferred.