Job Title
Quality Manager
About the Role
This is an exciting opportunity to join Kinetica as a Quality Manager. You will be responsible for managing a team of QA professionals, ensuring compliance with regulatory requirements, and driving quality excellence throughout the organization.
Main Responsibilities
* Oversee the Quality Management System, ensuring adherence to ISO 13485, EU MDR, UK MDR, and FDA regulations.
* Lead a team of QA professionals, fostering a culture of quality excellence and driving process improvements.
* Collaborate with manufacturing teams to ensure high-quality products.
Requirements
* Proven knowledge of medical device quality systems, including ISO 13485, 21 CFR Part 807, EU MDR, and UK MDR.
* Educational background: degree-level education.
* Leadership experience: substantial experience in a leadership or senior role within a quality department and team.