Description
My Client is a large Multinational Medical device company and is looking for a QA manager to provide quality information to customers, manage their quality systems, quality and compliance. With this they would be expected to provide support to Research and Development for Life Sciences products in Europe.Main Responsibilities;
- Provision of information related to quality and regulatory compliance for Food and Beverage customers in Europe, as well as for Biopharm customers in Europe. This includes completion of quality /regulatory questionnaires as well as investigations into new and specific questions for the customer's regulatory compliance and quality systems, files/submissions/quality systems.
- Management of the quality system for the Northern zone sales offices and maintenance of ISO90001 and ISO 13485 compliance as part of the Company Sarl approvals.
- To assist colleagues in the Life Sciences Quality Assurance and Regulatory Affairs Departments as directed by the Line Manager
- Induction training in quality systems for new starters
- Liaison with senior management on the internal audit programme /management reviews
- Performing both internal and external audits as required
- Provision of quality and regulatory support to Biopharm R&D. This includes advice on compliance to relevant regulations and requirements.
Education / Experience;
- 3 +Years Working Experience within a Medical Device company
- Quality Assurance / Regulatory Experience, preferably management but not essential.
- In depth Knowledge of ISO 9001 and ISO 13485 Quality Management Systems.
- Educated to degree level in Sciences or equivalent
- Excellent oral and written communication .
- The ability to present technical and product information clearly and concisely.
- Good attention to detail.
- Need a current driving license & be able to do some travel overseas.
My client is looking to pay up to £45,000 for the right candidate so if you believe you have the correct experience or know someone who has then send your/their CV/details and I will be in touch shortly. We offer a £200 referral reward for all successfully placed candidates. Sthree UK is acting as an Employment Agency in relation to this vacancy.