Job Overview
Kinetica is seeking an experienced Senior Quality Assurance Manager to oversee quality at our medical device company based in South Wales.
About the Role:
* Lead a team of QA and QC staff to ensure compliance with ISO 13485, EU MDR, UK MDR, and FDA requirements.
Responsibilities:
* Quality Management System Oversight: Manage and maintain the Quality Management System (QMS) to ensure it meets regulatory requirements.
* Team Leadership: Lead and manage a team of QA and QC professionals to achieve quality objectives.
* Process Improvement: Identify areas for process improvement and implement changes to enhance quality and efficiency.
* Collaboration: Work closely with cross-functional teams to ensure quality is integrated into all aspects of the business.
Requirements:
* Experience: Substantial experience in a leadership or senior role within a quality department and team.
* Education: Educated to degree level.
* Knowledge: Excellent knowledge of medical device quality systems including ISO13485, 21 CFR Part 807, EU MDR, and UK MDR.
We estimate the salary for this role to be around £60,000 - £80,000 per annum, depending on experience.