Cartosense
Website:
cartosense.com
Job details:
Cartosense's mission is to advance surgery by making decisions in the operation theater objective and data driven. We do this with technologies such as navigation, advanced visualization and robotics. What we do, changes lives every day. If you love to work on cutting-edge technology with the potential for outsized impact, come join us. You will work with some of the best minds on the leading edge of innovation.
Where you will see your impact
As a member of our Quality & Regulatory team, you will drive continuous improvement across our products and processes. Your main goals will be to manage various quality functions, including the management of our QMS, training, CAPA, supplier management, and conducting and responding to audits. This role will allow you to take strong ownership of all quality processes and will give you the opportunity to shape the quality structure of the organization.
Roles and Responsibilities
- Ensure regulatory compliance through quality systems implementation
- Conduct internal audits and supplier audits
- Conduct internal trainings for quality processes
- Manage regulatory submissions
- Lead the team for readiness to external audits
- Develop and maintain quality standards and procedures
Qualifications and Skills
- Bachelors or Masters with relevant experience in quality systems
- Experience with conducting internal audits and responding to external audits
- In-depth knowledge of ISO 13485 and regulatory processes for medical devices
- Sound understanding of the global regulatory landscape and international standards
- Excellent verbal and written communication skills
- Structured working style, attention to detail
Click on Apply to know more.