What are the responsibilities and job description for the QA Supervisor position at EPM Scientific?
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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