Quality Control Supervisor

Lincotek MedicalVandalia, OH

About The Position

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.

Requirements

  • High School Diploma/GED required
  • 2+ years of relevant quality, inspection, metrology, or manufacturing experience
  • 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

Nice To Haves

  • Bachelor's degree preferred
  • Supervisory or team leadership experience preferred

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 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

Benefits

  • 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.
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