Quality Management Systems Professional

3 weeks ago


Slough, Slough, United Kingdom GxPeople Global Full time
Job Title: Quality Management Systems Professional

Company Overview: GxPeople Global is a reputable Medical Device manufacturer seeking a skilled Quality Management Systems Professional to join their Quality team.

Salary: £50,000 - £65,000 per annum

Job Description: As a Quality Management Systems Professional, 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 experience in Medical Device Manufacturing and a good 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 desirable. Additionally, they should have a 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 required.

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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