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Quality Assurance Manager

  • Ref: 283758
  • Type: Direct Hire
  • Location: South Plainfield, NJ
  • Industry: Medical Devices
  • Job Level: Manager
  • Pay: Negotiable

Opportunity Description

Quality Assurance Manager needed for a direct hire in South Plainfield, NJ in the Medical Devices industry. The role of the Quality Assurance Manager prefers applicant have a Bachelor of Arts or Science degree in microbiology or related science, or the equivalent in education and experience.

Company Information

Our client is a leading provider of infection prevention with a focus on the healthcare sector and a mission to provide safety for individuals across the globe.

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.
  • 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 in 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.

Certifications

  • Preference is given for ASQ certification.