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QA Supervisor

EPM Scientific
New York, NY Full Time
POSTED ON 3/9/2025
AVAILABLE BEFORE 6/8/2025

We are seeking a highly skilled QA Supervisor to join a leading Medical Device company. In this role, you will be responsible for :

  • Maintaining a Quality Management System compliant with FDA regulations and driving continuous improvement.
  • Managing complaint handling and adverse event reporting, ensuring that processes, including sterilization, remain in a validated state.
  • Ensuring that released products meet specifications and educating, training, and advising the organization on quality and compliance matters.

Requirements :

  • Minimum of 5 years of experience in a senior role in Quality Assurance within an FDA-regulated environment, preferably in the medical devices industry.
  • Solid understanding of ISO13485 and international regulations.
  • Experience in managing and overseeing quality aspects in product development and production, preferably in disposable products.
  • Open-minded and always looking for improvement opportunities.
  • Ability to think creatively and proactively identify alternative solutions to problems.
  • Minimum Bachelor's degree in a relevant field of engineering and a qualification in Quality Assurance, such as Six Sigma, Lean, or ASQ.
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