About the Position
We are seeking a seasoned Quality Manager to join our team at Kinetica. As a key member of our organization, you will be responsible for overseeing quality, managing a team of QA professionals, and ensuring compliance with regulatory requirements.
Responsibilities
1. Maintain an effective Quality Management System, ensuring adherence to ISO 13485, EU MDR, UK MDR, and FDA regulations.
2. Lead a team of QA professionals, promoting a culture of quality excellence and driving process improvements.
3. Collaborate with manufacturing teams to ensure high-quality products.
4. Act as the company's representative for quality matters, ensuring effective communication with stakeholders.
Essential Qualifications
* Proven expertise in medical device quality systems, including ISO 13485, 21 CFR Part 807, EU MDR, and UK MDR.
* Degree-level education.
* Substantial leadership experience in a quality department and team.