We are seeking a talented individual to take on a challenging role within our organization. The successful candidate will possess in-depth knowledge of quality management systems and have a proven track record of working with medical devices.
About the Role
* Work collaboratively with stakeholders to develop and implement effective strategies for maintaining and improving our Quality Management System (QMS).
* Engage with regulatory bodies to secure and maintain ISO 13485 certification, a crucial standard for the medical device industry.
* Keep relevant parties informed of updates and changes through clear and prompt communication.
* Provide critical support to the Regulatory Affairs team by furnishing essential documentation to external customers, streamlining their product submissions.
* Participate in audits with various stakeholders, including notified bodies, regulatory agencies, and customers, to foster a culture of continuous improvement and knowledge sharing.
* Conduct regular audits of internal and supplier processes to ensure adherence to high standards of quality and compliance.
* Oversee the management of Corrective and Preventive Actions (CAPA) and Non-Conforming Product processes, working closely with action owners to guarantee timely resolution and closure.
Essential Skills and Qualifications
* A Bachelor's degree or higher in a relevant field is mandatory.
* Substantial experience working in the medical device or highly regulated industries is necessary.
This is a fantastic chance to join a prominent multinational organization committed to excellence in the life sciences sector.