The Quality Systems Consultant

Quality Systems Consultant

Position

• To create and implement Quality Management Systems to: ISO 13485, MDSAP, EU MDR, UK MDR, US FDA
• To 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 system
• The Quality Systems Consultant will provide support during clients' external Regulatory/Quality Audits
• Assist the QMS, Compliance and Training Delivery Manager in maintaining the quality management system to ISO 13485
• The 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 date
• To provide accurate quality management advice, in accordance with ISO 13485, MDSAP, EU MDR, UK MDR, US FDA
• The Quality Systems Consultant will administer the Company's Quality Management System to ensure continued compliance with ISO 13485
• To build and implement new systems for new/existing clients
• Ensure 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* system
• To attend clients' premises to conduct regulatory/ quality meetings, and/or clients' own external quality/regulatory audits
• The Quality Systems Consultant will conduct internal audits on clients' QMS

About You:

• Ideally a Scientific background
• ISO 13485 Internal Auditing experience is ideal
• Experience 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.com

Real 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