Job Quality Assurance Manager - Medical Devices -Berkshire -£45-55k Berkshire Technojobs - job offers
Quality Assurance Manager - Medical Devices -Berkshire -£45-55k
Job description:
A medium-sized, family owned Medical Device organisation based in Berkshire are entering a period of growth and as a result are looking for a Quality Assurance Manager to join their team. The focus of the Quality Assurance Manager is to support the management and leadership of the Quality team expands and ensure the quality systems remains compliant with current EU, FDA and GMP requirements. Key roles and responsibilities include: - Run, develop and continually improve the company's Quality Management System according to ISO13485, FDA &GMP - Ensure Technical/Design History Files are effectively maintained and comply with current MDD and FDA requirements - To develop QMS documentation to ensure it evolves in accordance with regulatory requirement - Management of CAPAs, non-conformance, root cause analysis, supplier and validation activity - Train staff on updated QA and RA documentation, as well as GMP guidelines - Prepare and audit schedule and conduct audits in accordance with ISO 13485, CFR 21 Part 820 and GMP The successful candidate will have: - Experience in Quality in the Medical Device Industry working to 93/42/EEC and ISO 13485 - Knowledge of GMP requirements - Previous experience of both internal and external auditing - Degree educated in a scientific or related field If this is an opportunity that interests you, apply now or contact Lillie Click here to contact this recruiter ...
Employer Name: Technojobs
Job short description: Electrical engineering technicians
Country: United Kingdom
Region: Berkshire
Contract duration: Permanent
Contract type: Full time
Source of job offer:
Department for Work and Pensions, Public Employment Services, United Kingdom
How to apply: Other - see free text
Salary currency: GBP
Salary period: Monthly
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