Want to progress your career in quality, while helping a provide software that is prospectively used for clinical and research decision making around the world.
Can you independently perform quality management system objectives to a high standard? Or pursue learning, self-development and sharing of knowledge with others.?
Help the head of QARA in managing the QMS.
Independently carry out all day to day QMS duties.
Interpret and implement all quality assurance standards and procedures
Carry out and support audits.
Coordinate with the companies partners, notified bodies, certification bodies and economic operators.
Help project teams to meet standards and requirements for their design, delivery, usability, risk management, compliance and product performance.
Supplier evaluation and approval activities.
Coordinate and support audits conducted by external providers as well as developing and managing internal audit processes, carrying out and scheduling internal audits with a team.
Evaluate audit findings and non-conformances and manage the implementation of corrective actions.
4 years experience in QA with medical devices.
Strong working knowledge of ISO13485
Good auditing experience
Root cause analysis, CAPA investigation.