Quality Control & Calibration Lead (MedTech Compliance)

Lincotek; Kentucky; On-site; USD 70,000 - 110,000; Full time

Job summary

The Quality Control Supervisor at Lincotek leads the daily activities of the Quality Control department, supervising Inspectors, Calibration personnel, and external resources to ensure timely product inspection and release.

This role ensures compliance with FDA/ISO regulations, reviews DHRs/CoCs, and provides technical leadership in metrology, GD&T, and continuous improvement while coaching staff for operational excellence and customer satisfaction.

Qualifications

• Experience leading quality control teams in medical device manufacturing.
• Strong knowledge of FDA QSR/ISO 13485 compliance and documentation.
• Proficiency in metrology, GD&T, and measurement systems.

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.

Job description

The Quality Control Supervisor at Lincotek leads the daily activities of the Quality Control department, supervising Inspectors, Calibration personnel, and external resources to ensure timely product inspection and release.

This role ensures compliance with FDA/ISO regulations, reviews DHRs/CoCs, and provides technical leadership in metrology, GD&T, and continuous improvement while coaching staff for operational excellence and customer satisfaction.