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Quality Assurance Manager

  • Ref: 283087
  • Type: Direct Hire
  • Location: Chester, NY
  • Industry: Medical Devices
  • Job Level: Experienced Non-Manager
  • Pay: Negotiable

Opportunity Description

Global Health Technology Company located in the Chester, NY is currently seeking a Quality System/Regulatory Compliance Manager.

Company Information

Our client, a leading provider of infection prevention, focuses on healthcare and the safety of people.

Job Duties

  • Ensures internal Quality Systems audits are performed Conduct audits of vendors
  • Ensures all required reporting, trending, and metrics are properly prepared and submitted in a timely manner.
  • Ensures that FDA rules and regulations are adhered to.
  • Ensure that all processing records are in compliance with processing specifications and Quality Systems/Regulatory Compliance requirements prior to product release.
  • Has authority and responsibility to withhold release approval for Customer product not meeting acceptance criteria.
  • Should a question arise regarding product release or in regards to the quality of the product, service provided or regulatory issue, the issue will be discussed through appropriate management channels, ultimately to be brought before the Director of Quality Systems/Regulatory Compliance for resolution.
  • Provide facility Quality Systems and Regulatory Compliance leadership and administration by ensuring all relevant Food and Drug Administration (FDA) regulations, Corporate policies, current ISO registration requirements, AAMI/ANSI/ISO 11137/11135 and EN 550/552, EN 46000 and other appropriate standards are met by understanding current requirements and by development, generation and approval of procedures which are disseminated and controlled as documented
  • Ensure process control through review of operations records including, but not limited to measurement instrumentation, spectrophotometers, timer changes, preconditioning, aeration, and maintenance programs
  • Ensure that all processing records are in compliance with processing specifications and Quality Systems/Regulatory Compliance requirements prior to product release.
  • Ensure facility internal audits are conducted and the integrity of the process is maintained.
  • Manages, monitors, and mentors QS/RC Analysts and QS/RC Technicians to ensure effective performance and continued growth and development.
  • Hiring decisions for Provides leadership and assistance to facility operations in properly documenting and expeditiously resolving Customer complaints.
  • Provides leadership and assistance to facility operations in properly documenting and expeditiously any CAPA issues.

Education

Bachelor of Arts or Science degree in microbiology or related science, or the equivalent of education and experience preferred.

Experience & Skills Required

  • A Minimum of five (5) years of experience in medical device manufacturing or in sterilization operations, and Quality System FDA regulations (QSR) and validation is preferred.
  • ISO 13485:2003 standard and AAMI industrial sterilization methods experience preferred.

Certifications

Preference is given for ASQ certification.