17 ott - Bardi
LINCOTEK
SUMMARY
The Quality Control Supervisor is responsible for leading the daily activities of the Quality Control department, including supervision of Quality Inspectors, Calibration personnel, and external inspection resources as assigned. This role ensures timely product inspection and release while maintaining compliance with applicable regulatory requirements, customer specifications, and internal quality standards. The supervisor provides technical leadership in inspection methods, metrology, calibration, and continuous improvement, while coaching and developing personnel to support operational excellence and customer satisfaction. Ensures regulatory requirements are met for the medical industry including FDA/ISO regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- 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.
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