ABOUT THE JOB

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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.

MAIN RESPONSIBILITIES

- - 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.

- Non-Conformity & CAPA: Manage Non-Conformity processes along with Corrective and Preventive Actions (CAPA).

- Documentation & Compliance: Coordinate the preparation of quality documentation required for regulatory activities and certification audits, applying a risk-based approach across the entire QMS.

- Internal Audits: Plan and execute internal audits.

- Subcontractor Audits: Conduct audits at subcontractor facilities, including external laboratories.

- 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.

- Quality Plans: Review, prepare, and approve quality plans with clients and suppliers of outsourced services/processes.

- Procedures & Instructions: Review and approve procedures and work instructions.

- KPI Analysis: Manage KPI trend analysis to evaluate overall quality performance.

- Continuous Improvement: Identify quality issues or areas for improvement and propose effective solutions.

- Product Release: Define and implement product release flows (including issuing release documentation) in compliance with applicable medical device regulations. xkiyazw

- Scrap & Defect Management: Define and manage workflows for scrap management and defect reporting, ensuring full compliance with medical standards.

SUPERVISORY RESPONSIBILITY none

📌 Quality Assurance Specialist (Busano)
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