We are looking for a seasoned professional to assume a pivotal role in our organization. The ideal candidate will have a deep understanding of quality management systems and significant experience working with medical devices.
About the Job
* Develop and maintain a robust Quality Management System (QMS) that ensures efficiency, compliance, and excellence through close collaboration with stakeholders.
* Work closely with regulatory bodies to achieve and sustain ISO 13485 certification, a vital standard for the medical device industry.
* Communicate effectively with relevant parties, keeping them informed of updates and changes in a timely manner.
* Support the Regulatory Affairs team by providing critical documentation to external customers, facilitating their product submissions.
* Participate actively in audits with various stakeholders, including notified bodies, regulatory agencies, and customers, to promote a culture of continuous improvement and knowledge sharing.
* Conduct regular internal and supplier audits to ensure adherence to high standards of quality and compliance.
* Manage the tracking of Corrective and Preventive Actions (CAPA) and Non-Conforming Product processes, collaborating closely with action owners to guarantee timely resolution and closure.
Key Responsibilities
* Bachelor's degree or higher in a relevant field is required.
* Extensive experience working in the medical device or highly regulated industries is essential.
This is an excellent opportunity to contribute to a leading multinational organization dedicated to excellence in the life sciences sector.