Quality Assurance and Compliance Manager
6 days ago
Quality Assurance and Compliance Manager
About the Company:
Kinetica is seeking an experienced Quality Assurance and Compliance Manager to oversee quality at our medical device company based in South Wales.
Responsibilities:
- Manage the Quality Management System to ensure compliance with ISO 13485, EU MDR, UK MDR, and FDA requirements.
- Lead a team of QA and QC staff to achieve quality objectives.
- Provide quality support to manufacturing and collaborate with departmental heads on quality training.
- Act as the company representative for quality and oversee QC processes.
- Maintain key quality systems, including CAPA, complaints management, and sterilization.
- Ensure quality is integrated into all departments and facilitate data analysis.
- Lead internal and external audits, ensuring the site remains compliant with regulatory requirements.
Requirements:
- Excellent knowledge of medical device quality systems.
- Educated to degree level.
- Substantial experience in a leadership or senior role within a quality department and team.
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