Medical Device QMS Expert
2 days ago
Company Overview: GxPeople Global is a leading Medical Device manufacturer seeking an experienced Medical Device QMS Expert to join their Quality team.
Salary: £70,000 - £90,000 per annum
Job Description: As a Medical Device QMS Expert, you will be responsible for ensuring the Quality Management System is compliant with regulatory requirements, including ISO 13485:2016 and MDSAP. You will develop and update QMS procedures and associated Work Instructions and documentation, manage CAPAs, and conduct internal audits. Additionally, you will provide QMS Induction training for new starters and contribute to product Risk Assessment. You will also be involved in reviewing and approving processes, conducting gap analysis for standards and regulations, and planning and conducting supplier audits.
Required Skills and Qualifications: The ideal candidate will have extensive experience in Medical Device Manufacturing and a deep understanding of Quality Assurance principles. They should be familiar with Quality Investigational tools such as Five Whys Technique, Fish Bone Technique, Pareto, FMEA, and Ishikawa. Lead Auditor training and certification are highly desirable. Additionally, they should have a strong working knowledge of ISO 13485:2016, MDSAP, Medical Devices Directive (93/42/EEC), and Medical Devices Regulations (EU) MDR 2017/745. Experience with Risk Management to ISO 14971 is also essential.
Benefits: We offer a competitive salary and a comprehensive benefits package including health insurance, pension scheme, and opportunities for professional development. If you are looking for a challenging role with a well-established business that values quality and excellence, please apply.
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