Quality Control Supervisor
$67,000–$105,000 year
On-site · Plymouth, Minnesota, United States
Job Summary
Quality Control Supervisor role overseeing a team of Quality Control Technicians; lead and mentor the QC team; manage QC processes, inspections, testing, and audits to ensure compliance with FDA/ISO 13485 and GMP/GLP; drive CAPA, root-cause analyses, and corrective/preventive actions; utilize SPC and FMEA to monitor and improve process capability and product quality; lead internal audits, generate quality metrics and reports for senior management; ensure calibration, maintenance, and proper use of QC equipment; contribute to continuous improvement initiatives using Lean Six Sigma; coordinate qualification activities, validation protocols, and documentation to maintain compliance across production stages.
Required Qualifications
- Minimum of 5+ years of experience in FDA/ISO 13485 regulated Medical Device manufacturing quality environments
- Experience leading Quality Control Technicians
- Experience with calibration, maintenance, and proper use of quality control equipment
- Experience with inspection, in-process/final inspection, and quality records
- Experience performing internal audits and ensuring adherence to GMP/GLP
- Knowledge of SPC and FMEA for process capability and product quality
- Understanding of CAPA, root cause analysis, and corrective/preventive actions
- Six Sigma knowledge and/or certifications desired
- Ability to work onsite with in-person collaboration
- High school diploma or vocational education or equivalent; higher degrees desired (Associates/Bachelor’s)
- Willingness to travel up to 10%
- US work authorization; relocation benefits not provided
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