Quality Assurance Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/878vg5

h3ABOUT THE JOB /h3 pThe Quality Assurance Specialist is responsible for developing and maintaining the company’s Quality Management System (QMS). Working closely with Top Management, this role reports directly to the Site Quality Manager and collaborates cross-functionally across all plant departments. /p h3MAIN RESPONSIBILITIES /h3 ul liQMS Management: Maintain and manage the QMS to ensure all manufacturing processes and services supplied by Lincotek comply with regulatory standards and customer contractual requirements. /li liNon-Conformity CAPA: Manage Non-Conformity processes along with Corrective and Preventive Actions (CAPA). /li liDocumentation Compliance: Coordinate the preparation of quality documentation required for regulatory activities and certification audits, applying a risk-based approach across the entire QMS. /li liInternal Audits: Plan and execute internal audits. /li liSubcontractor Audits: Conduct audits at subcontractor facilities, including external laboratories. /li liTraining Program: Define and implement, in collaboration with Top Management,



the quality training program for all personnel involved in activities impacting service quality. /li liCustomer Complaints Issue Resolution: Manage non-conformities, customer complaints, and preventive actions. /li liQuality Plans: Review, prepare, and approve quality plans with clients and suppliers of outsourced services/processes. /li liProcedures Instructions: Review and approve procedures and work instructions. /li liKPI Analysis: Manage KPI trend analysis to evaluate overall quality performance. /li liContinuous Improvement: Identify quality issues or areas for improvement and propose effective solutions. /li liProduct Release: Define and implement product release flows (including issuing release documentation) in compliance with applicable medical device regulations. /li liScrap Defect Management: Define and manage workflows for scrap management and defect reporting, ensuring full compliance with medical standards. /li /ul h3SUPERVISORY RESPONSIBILITY /h3 pnone /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/878vg5