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.
