Job Reference: J5631754
Updated On: 20/06/2019
Status: Open to Applications
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Quality Assurance Manager
Role OverviewWe are currently looking for a Quality Assurance Manager to join a leading Medical Device company based in the London area. As the Quality Assurance Manager you will be responsible for managing and developing the ISO13485 compliant Quality Management System.
Key Duties and ResponsibilitiesYour duties as the Quality Assurance Manager will be varied however the key duties and responsibilities are as follows:
1. You will understand current and evolving Medical Device regulations to ensure that the Quality Management System QMS remains compliant. You will provide overview and updates of the QMS to the Site Leadership Team.
2. As the Quality Assurance Manager, you will drive a Quality Culture throughout, whilst also acting as the main point of contact regarding Medical Device Quality related issues.
3. With the continuous development of the Quality System, you will perform and host Audits, and will follow up on Audit findings, including oversight of CAPA processes.
Role RequirementsTo be successful in your application to this exciting opportunity as the Quality Manager - Medical Device we are looking to identify the following on your profile and past history:
1. Previous experience working within a Medical Device business, managing a Quality Assurance Function, ensuring ISO 13485 compliance.
2. Exposure to regulatory agencies, including the MHRA and FDA
Key Words: Quality Assurance | QA | Quality Manager | Medical Device | ISO 13485 | MHRA | FDA | 21 CFR | Quality Systems | QMS | Audit
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