We are seeking a highly skilled professional to assume a key role in our organization. The ideal candidate will have extensive experience working with medical devices and a profound understanding of quality management systems.
About the Position
* Collaborate closely with stakeholders to maintain and continually improve our Quality Management System (QMS), ensuring efficiency, compliance, and excellence.
* Work diligently with regulatory bodies to obtain and maintain ISO 13485 certification, a critical standard for the medical device industry.
* Communicate updates and changes promptly to relevant authorities, customers, and stakeholders, fostering transparency and trust.
* Support the Regulatory Affairs team in providing essential documentation to external customers, facilitating their product submissions.
* Participate actively in audits with notified bodies, regulatory agencies, and customers, ensuring seamless collaboration, knowledge sharing, and continuous improvement.
* Conduct regular internal and supplier audits to uphold high standards of quality, compliance, and integrity.
* Manage the tracking of Corrective and Preventive Actions (CAPA) and Non-Conforming Product processes, collaborating closely with action owners to ensure timely resolution and closure.
Key Requirements
* Bachelor's degree or higher in a relevant field is required.
* Proven experience working in the medical device or highly regulated industries is essential.
This is an exciting opportunity to contribute to a leading multinational organization dedicated to excellence in the life sciences sector.