The Quality Systems Consultant

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Quality Systems Consultant PositionTo create and implement Quality Management Systems to: ISO 13485, MDSAP, EU MDR, UK MDR, US FDATo support and maintain contracted clients' Quality Management Systems to: ISO 13485, MDSAP, EU MDR, UK MDR, US FDA either via Activ*or their paper-based quality systemThe Quality Systems Consultant will provide support during clients' external Regulatory/Quality AuditsAssist the QMS, Compliance and Training Delivery Manager in maintaining the quality management system to ISO 13485The Quality Systems Consultant will provide advice to those clients on QMS related queries Key Responsibilities: Ensure all contracted clients, with paper-based quality management systems, are kept in compliance with the standard complied to, and remain up to dateTo provide accurate quality management advice, in accordance with ISO 13485, MDSAP, EU MDR, UK MDR, US FDAThe Quality Systems Consultant will administer the Company's Quality Management System to ensure continued compliance with ISO 13485To build and implement new systems for new/existing clientsEnsure all contracted Activ* clients' systems are kept in compliance with the standard complied to, and are updated in line with notifications received by their Activ* systemTo attend clients' premises to conduct regulatory/ quality meetings, and/or clients' own external quality/regulatory auditsThe Quality Systems Consultant will conduct internal audits on clients' QMS About You: Ideally a Scientific backgroundISO 13485 Internal Auditing experience is idealExperience in dealing with Regulatory bodies: EU Notified Bodies, EU Competent Authorities, UK Approved Bodies in an auditing capacity To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales