QA Lead - Medical Devices - North Yorkshire - £competitive
* Our client is a rapidly growing Medical Devices company that specialise in surgical and clinical products
* This role would be working within a highly dynamic, friendly and new Quality & Regulatory Affairs team
* They have just moved to brand new offices, offer excellent training and an amazing progression plan
* Ultimate responsibility for the quality of all products.
* Responsible for ensuring compliance to ISO9001, ISO13485 and 21 cfr pt820 and maintaining certification where applicable
* Management of existing internal standard operating procedures
* Creation and management of new internal operating procedures as required for continuous improvement.
* Ensuring incoming product conformance with Product Specification through managing incoming goods inspections.
* Management and implementation of an effective change control process.
* Organization of regular internal quality meetings.
* Advising on remedial work and supervision of remedial work implementation with Engineering services.
* Liaison with Head of Design & Regulatory, Regulatory Affairs Manager and company Directors on quality issues.
* Technical Investigations into customer complaints (when escalated by complaints officer) and support Root cause investigation
* CAPA - Ensure all quality issues are recorded and investigated resulting in effective close out with appropriate corrective and preventive action to reduce risk reoccurrence.
* Assisting Regulatory Affairs Manager in the preparation and coordination of annual regulatory & quality system audits.
* Assist Regulatory Affairs Manager with regular internal regulatory and quality meetings.
* Support Regulatory Affairs Manager in the preparation of documents for regulatory submissions.
* Degree in sciences, engineering, medical sectors or equivalent
* Experience within the medical devices market in a QA function
* Excellent leadership and management skills
What should you do next?
This QA Lead role is one not to be missed; it encompasses the opportunity to make a difference in a highly dynamic and growing medical devices company! To discuss further, please submit your current CV.
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role