Quality Control Supervisor

Lincotek Medical; Vandalia (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

Lincotek Medical is seeking a Lead Quality Control & Calibration Supervisor in Vandalia, Ohio to guide the QC team and ensure regulated medical products meet quality and release standards.

You will lead inspectors and calibration staff, review DHRs/CoCs, and provide guidance on GD&T and metrology while ensuring FDA/ISO compliance and continuous improvement.

Qualifications

• High School Diploma/GED; Bachelor's degree preferred.
• 2+ years of quality, inspection, metrology, or manufacturing experience.
• Supervisory or team leadership experience preferred.
• Knowledge of FDA Quality System Regulations, ISO 13485, and Good Documentation Practices.
• Ability to interpret engineering drawings and GD&T.
• Knowledge of metrology, calibration systems, and precision measurement equipment.
• Experience with SPC, MSA, Gauge R&R, and statistical quality techniques.
• Strong analytical, problem-solving, communication, and leadership skills.
• Proficiency with Microsoft Office and quality-related software systems.

Responsibilities

• Lead and supervise Quality Inspectors, Calibration personnel, and external inspection resources.
• Coordinate daily QC activities and resources to support production priorities.
• Review and approve Device History Records (DHRs), Certificates of Compliance (CoCs), and other release documentation.
• Provide technical guidance on inspection methods, metrology, engineering drawings, and GD&T.
• Oversee calibration activities and ensure measurement equipment meets established requirements.
• Support investigations involving nonconforming products, root cause analysis, and corrective actions.
• Utilize statistical quality tools, including SPC, MSA, and Gauge R&R.
• Support internal, customer, vendor, ISO and FDA audits.
• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and company quality procedures.
• Coach, mentor, and develop QC team members while establishing strong performance standards.
• Partner cross-functionally with Operations, Engineering, and other teams to continuously improve quality and efficiency.

Skills

Leadership

Quality assurance

Metrology

GD&T

Regulatory compliance

Root cause analysis

Statistical methods

Documentation practices

Problem solving

Communication

Education

High School Diploma/GED; Bachelor's preferred

Job description

Lead Quality. Drive Excellence. Make an Impact.

We are seeking an experienced Quality Control & Calibration Supervisor to lead our QC team and play a key role in ensuring the quality, compliance, and timely release of products within a regulated medical manufacturing environment.

This is an excellent opportunity for a hands-on quality professional who enjoys leading people, solving problems, working with precision measurement and metrology, and driving continuous improvement.

What You'll Do

• Lead and supervise Quality Inspectors, Calibration personnel, and external inspection resources
• Coordinate daily QC activities and resources to support production priorities
• Review and approve Device History Records (DHRs), Certificates of Compliance (CoCs), and other product-release documentation
• Provide technical guidance on inspection methods, metrology, engineering drawings, and GD&T
• Oversee calibration activities and ensure measurement equipment meets established requirements
• Support investigations involving nonconforming products, root cause analysis, and corrective actions
• Utilize statistical quality tools, including SPC, MSA, and Gauge R&R
• Support internal, customer, vendor, ISO and FDA audits
• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and company quality procedures
• Coach, mentor, and develop QC team members while establishing strong performance standards
• Partner cross-functionally with Operations, Engineering, and other teams to continuously improve quality and efficiency

What We're Looking For

• High School Diploma/GED required; Bachelor's degree preferred
• 2+ years of relevant quality, inspection, metrology, or manufacturing experience
• Supervisory or team leadership experience preferred
• Strong knowledge of FDA Quality System Regulations, ISO 13485, and Good Documentation Practices
• Ability to interpret engineering drawings and GD&T
• Knowledge of metrology, calibration systems, and precision measurement equipment
• Experience with SPC, MSA, Gauge R&R, and statistical quality techniques
• Strong analytical, problem-solving, communication, and leadership skills
• Proficiency with Microsoft Office and quality-related software systems

Why Join Us?

This is an opportunity to take a leadership role within a quality-driven medical manufacturing environment, where your expertise will directly contribute to product quality, regulatory compliance, operational excellence, and customer satisfaction.

If you are a quality professional ready to lead a team, strengthen quality processes, and make a measurable impact, we'd love to hear from you.