Quality Control Supervisor

PhilipsPlymouth, MN
$67,000 - $105,000Onsite

About The Position

The Quality Control Supervisor is responsible for supervising/leading a team of Quality Control Technicians, overseeing quality control processes and procedures to ensure compliance with all applicable standards.

Requirements

  • Minimum of 5+ years’ experience in FDA/ISO 13485 regulated Medical Device manufacturing quality environments, with a focus on production controls, supporting validations, administering calibration, maintenance, and proper use of quality control equipment, quality records, incoming/in-process/final Inspection, and continuous/process improvement.
  • Proven experience leading Quality Control Technicians, providing mentorship and guidance.
  • Proven experience working in a clean room environment, ensuring adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
  • Experience with laboratory hygiene programs and lab equipment maintenance, to ensure accuracy and reliability of test results, adhering to regulatory standards and quality control measures.
  • Minimum of a Highschool Diploma/ Vocational Education or equivalent.
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
  • For this position, you must reside in or within commuting distance to Plymouth, MN.

Nice To Haves

  • Associates or Bachelor's Degree desired.
  • Six Sigma knowledge and/or certifications desired.

Responsibilities

  • Supervises and leads a team of Quality Control Technicians, providing guidance, mentorship, and actively contributing to employee selection, performance management, compensation management, and career development.
  • Develops, implements, and oversees quality control processes and procedures, ensuring compliance with organizational requirements and industry standards across all stages of production.
  • Coordinates and manages day-to-day quality control activities, including inspections, testing, and audits, to ensure products consistently meet or exceed established quality standards.
  • Works on addressing varied but typically not highly complex issues or problems by exercising judgement and interpretation within existing procedures and policies to determine appropriate action.
  • Coordinates the root cause analysis and problem-solving sessions to address quality issues, guiding the team in developing and implementing effective corrective and preventive actions and possesses basic understanding of Corrective and Preventive Action (CAPA), applicable regulations, requirements, and standards.
  • Utilizes advanced quality management tools, such as Statistical Process Control (SPC) and Failure Mode and Effects Analysis (FMEA), to monitor and improve process capabilities and product quality.
  • Leads and reviews quality control documentation, including inspection records, audit reports, and validation protocols, ensuring accuracy and compliance with internal and external requirements.
  • Leads regular internal audits to ensure adherence to quality control principles and industry standards, addressing any non-conformances identified and ensuring continuous improvement.
  • Develops, monitors and analyzes key quality performance metrics, generating detailed reports and actionable insights for senior management to support informed decision-making and strategic planning.
  • Ensures the calibration, maintenance, and proper use of quality control equipment and instrumentation, guaranteeing accurate and reliable measurements for quality assessments.
  • Leads continuous improvement initiatives within the quality control department, applying Lean Six Sigma methodologies to optimize processes, reduce waste, and improve overall product quality.

Benefits

  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement
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