Quality Compliance Team Leader

Orion Electrotech Ltd
Plymouth, UK
23 Jul 2019
03 Sep 2019
Contract Type
Full Time
We are a market leading Medical Device company and due to continued growth, we have an exciting opportunity available for a Quality Compliance Leader to join our team.

As our new Quality Compliance Leader, you 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 of plant CAPA records. Reporting on 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 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 corporate.
*Create and maintain systems for efficient retrieval of data and records in audits.
*Support the Environmental Management Team to maintain the Environmental Management system in accordance with ISO14001 and applicable regulations.

*Experience in the Quality / Regulatory arena preferably in a manufacturing environment.
*At least 3-5yrs leadership experience.
*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.
*Preferably a degree in Engineering, Science, Quality Assurance or Business Management. If not in QA, then some form of Quality Management qualification is required.
*Must be Lead Auditor Qualified to ISO13485 (Medical Devices) at a minimum.

Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.

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