Quality Control & Calibration Supervisor

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

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.

SUPERVISORY RESPONSIBILITIES

• Directly supervise Quality Control personnel, including Quality Inspectors, Calibration personnel, and external inspection resources as assigned.


• Effectively evaluates QC department's performance and provides coaching and mentoring to set performance standards, assess performance capability, and prescribe remediation (including coaching, learning assignments, and training opportunities).


• Conduct hiring, disciplining and terminating according to the implemented policies in a fair and defensible professional manner.


• Motivates their team to define and meet performance expectations and, while collaborating effectively across functional boundaries.


• Coordinate daily work assignments and resources to meet production priorities while maintaining compliance with quality and regulatory requirements.


• Other duties as assigned.