Quality Compliance Leader - Permanent - Plymouth
Are you a ISO 13485 Lead Auditor and an experienced team leader?
A global medical device company are looking to recruit a Quality Compliance Leader who will be responsible for the management and maintenance of the Quality Management Systems including CAPA and Internal/External/Supplier Audit function. This position reports to the Associate Director Quality Management.
- Maintenance and of plant CAPA records. Reporting of trends at CAPA and Management review meetings, coordination of CAPA Clinics and CAPA governance processes.
- Management and continual improvement of the site internal audit programme. Reporting on trends / developments for SLT and Management Review meetings.
- Support and maintain the Supplier Management program. Carry out Supplier audits as required by the Supplier Audit Plan in accordance with the relevant national and international standards.
- Develop, maintain, execute and administer the Internal Audit program, including the competency and training of the Lead Auditor Team.
- Maintain a current awareness of national and international regulatory requirements and relevant developments in the medical device industry.
- Establish and maintain certification to the required international or national standards as directed by the Associate Director Quality Management and Manufacturing Director, in accordance with the requirements of the Medical Device Single Audit Program (MDSAP) and other jurisdictional regulations.
- Prepare and host on-site audits from Regulatory Bodies, Customers, Unit PAS and BDX corporate.
- Experience in the Quality / Regulatory arena preferably in a manufacturing environment.
- Must have exposure to the requirements of ISO 13485 and FDA 21 CFR 820 along with some exposure to all other elements of the job description.
- Experience in preparing and hosting external audits for example FDA, CFDA, ISO.
- Must be Lead Auditor Qualified to ISO13485 (Medical Devices) at a minimum.
Apply today to express your interest!