Medical Devices QC & Calibration Lead

Lincotek; Rubbiano; À distance; EUR 50 000 - 70 000; Plein temps

Résumé du poste

Lincotek in Italy is seeking a Quality Control Supervisor to lead the QC department, supervise inspectors and calibration personnel, ensure timely inspection and product release, and maintain compliance with FDA/ISO quality standards.

You will provide technical leadership in inspection methods, metrology, GD&T, and calibration, while coaching staff to drive continuous improvement and operational excellence in support of customer satisfaction.

Responsabilités

• Supervise the daily activities of the Quality Control department, including Quality Inspectors, Calibration personnel, and external inspection resources as assigned.
• Ensure inspection activities support production priorities and assigned times while maintaining compliance with quality standards and customer requirements.
• Review and approve Device History Records (DHRs), Certificates of Compliance (CoCs), and other quality documentation required for product release.
• Ensure inspection methods, metrology practices, and calibration activities are performed in accordance with company procedures and applicable standards.
• Provide technical guidance on inspection techniques, engineering drawings, and Geometric Dimensioning & Tolerancing (GD&T).
• Support investigations of nonconforming products and implementation of corrective actions as appropriate.
• As needed, support external audit functions. Includes participating with vendor, ISO and/or FDA audits.
• Ensure compliance with FDA Quality System Regulations, ISO 13485, and company quality system requirements.
• Experience with statistical principles, data collection and reduction utilizing appropriate software tools.
• Perform other duties as assigned.

Description du poste

Lincotek in Italy is seeking a Quality Control Supervisor to lead the QC department, supervise inspectors and calibration personnel, ensure timely inspection and product release, and maintain compliance with FDA/ISO quality standards.

You will provide technical leadership in inspection methods, metrology, GD&T, and calibration, while coaching staff to drive continuous improvement and operational excellence in support of customer satisfaction.