Quality Technician II
Talent Software Services
Description: Hybrid with full onsite as needed
Interview process: 2 rounds of interviews.
Job Purpose:
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.
Key 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.
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.
Interview process: 2 rounds of interviews.
Job Purpose:
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.
Key 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.
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.
Vacancy posted 3 days ago
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