The 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.
QMS Management: Maintain and manage the QMS to ensure all manufacturing processes and services supplied by Lincotek comply with regulatory standards and customer contractual requirements.
Coordinate the preparation of quality documentation required for regulatory activities and certification audits, applying a risk-based approach across the entire QMS.
Training Program: Define and implement, in collaboration with Top Management,



the quality training program for all personnel involved in activities impacting service quality.
Customer Complaints & Issue Resolution: Manage non-conformities, customer complaints, and preventive actions.
KPI Analysis: Manage KPI trend analysis to evaluate overall quality performance.
Continuous Improvement: Product Release: Define and implement product release flows (including issuing release documentation) in compliance with applicable medical device regulations. Scrap & Defect Management: Define and manage workflows for scrap management and defect reporting, ensuring full compliance with medical standards.

📌 Quality Specialist (Italia)
🏢 Intervieweb
📍 Italia