Job Description
Job Title: Technician, Quality
Reports To: Manager, Quality
Position Location:Buffalo, NY
FLSA Status: Non-Exempt
Position Summary:
Responsible for quality system processes designed to ensure continuous flow of incoming and outgoing materials consistent with established standards and regulations including FDA 21 CFR 820, ISO 13485, and appropriate EU regulations. Ensures compliance in QC areas including review and generation of information for incoming materials and product release. Ensures compliance in the areas of equipment qualification and calibration, supplier qualification and management, and document control as needed. Ensures continued improvement and compliance with relevant FDA, ISO 13485, and EU regulations by participating in audit responses, and deviation, nonconformance, complaint, and CAPA processes as necessary. Promotes and participate in training activities related to the quality management system and product quality, safety and effi...
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