Quality Assurance Specialist
16 hours ago
Company Overview: GxPeople Global is a well-established Medical Device manufacturer seeking a skilled Quality Assurance Specialist to join their Quality team.
Salary: £60,000 - £80,000 per annum
Job Description: As a Quality Assurance Specialist, you will be responsible for supporting the QA/RA team and wider business with issues related to overall quality assurance, control, and compliance. Key responsibilities include developing and updating QMS procedures and associated Work Instructions and documentation, ensuring compliance to ISO 13485:2016 and MDSAP regulations, and managing CAPAs. You will also be involved in the review and approval of processes, conducting gap analysis for standards and regulations, and providing QMS Induction training for new starters.
Required Skills and Qualifications: The ideal candidate will have experience and working knowledge of Quality Assurance, particularly in Medical Device Manufacturing. 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 also 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: In addition to a competitive salary, we offer 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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