About Kinetica
Kinetica is a leading medical device company based in South Wales, dedicated to delivering high-quality products while ensuring regulatory compliance.
Job Overview
We are seeking an experienced Quality Manager to oversee quality at our organization. This role involves managing a team of QA professionals, ensuring adherence to ISO 13485, EU MDR, UK MDR, and FDA regulations.
Key Responsibilities
* Ensure compliance with regulatory requirements by maintaining an effective Quality Management System.
* Lead a team of QA professionals, fostering a culture of quality excellence and driving process improvements.
* Provide guidance and support to manufacturing teams to ensure high-quality products.
* Represent the company in quality matters, ensuring effective communication with stakeholders.
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.