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The Quality Systems Consultant

Premium Job From Real Staffing
Recruiter: Real Staffing
Listed on: 14th June
Location: Warwickshire
Salary/Rate: £50,000 - £60,000
Type: Permanent
Start Date: ASAP

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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