QA Supervisor

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.