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Quality Assurance Supervisor

2 months ago

Rochester, New York, United States HIGHPOWER Validation Testing & Lab Services Full time

Quality Control Manager for Testing Facility

HIGHPOWER Validation Testing & Lab Services, Inc. is seeking a dedicated Quality Control Manager to oversee and enhance our established ISO 17025 quality framework while ensuring compliance in our expanding laboratory. The ideal candidate will possess a strong work ethic, be detail-oriented, and have expertise in ISO 17025, 13485, 9001, or FDA/GMP quality systems. Exceptional interpersonal skills and experience in a regulated setting are essential. The selected individual will report directly to the General Manager of the company. Key responsibilities include:

  • Executing corrective and preventive measures
  • Investigating complaints and out-of-specification (O.O.S) results
  • Conducting internal and external audits
  • Managing documentation within the quality management system
  • Reviewing QA processes for completed studies and raw data
  • Maintaining ISO Certifications and Accreditations
  • Updating the company Quality Manual
  • Assessing suppliers and service providers
  • Delivering quality system training to staff
  • Implementing initiatives for quality process improvements
  • Supporting Executive Management as needed

This position requires in-office presence with standard working hours.

Required Skills: Strong written and verbal communication abilities, proficiency in computer applications, and familiarity with Microsoft Word, Microsoft Excel, Adobe, and Smartsheet are advantageous. A solid understanding and practical experience in ISO 17025, 13485, 9001, or FDA/GMP quality systems are mandatory. Candidates must be organized, quick learners, team-oriented, and capable of managing multiple tasks in a dynamic laboratory environment.

Employee Benefits: Competitive salary, comprehensive Medical, Dental, and Vision Insurance, a 401(k) plan with matching contributions, holiday bonuses, paid time off, and various voluntary insurance options including Life, Disability, and Accident Insurance.

Minimum Qualifications: An Associate's degree with relevant experience or a minimum of 5 years in corporate quality leadership roles.