QA Specialist

City of London  ‐ Onsite
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Description

The Role

This is a new position reporting to the Quality and Regulatory Assurance Manager with responsibility for the Design Control and Risk Management activities for a Medical Device client of mine based in London.

Purpose of the role

To manage the design and development of a Diagnostic System including ownership of the Risk Management process. Influence, and where applicable educate team members to ensure compliant development and risk management culture within the organisation.

Key Responsibilities of the role are to:

Work under the guidance of the Quality and Regulatory Assurance Manager and lead the company's Design Control and Risk Management obligations in line with 21 CFR 820 and ISO 13485

Take ownership of:
  • Design and Risk Control process
  • DHF/Technical File compilation and maintenance
  • Risk Management File maintenance
  • Design Review
  • Training and effectiveness of the product realization process


Reporting
  • Immediate line reporting to the QARA Manager
  • No Line Management


Qualifications
  • Bachelor's degree in a Scientific or Engineering subject
  • Demonstrable knowledge of the ISO 13485 standard, 21 CFR 820 Design Controls
  • Demonstrable success in managing Risk Management Programmes to ISO 14971
  • Experience in multisite environments involving internal and external project teams


The following would be advantageous

Knowledge of:
  • ISO 62304
  • US and EU regulatory submission process
  • Clinical Trials
  • Experience in NGS/Molecular Diagnostic products
  • Experience in both small and large organisations


Skills and Behaviour
  • Maturity to handle sensitive issues with the appropriate level of discretion
  • Strong organisational and operational management skills; ability to align priorities and manage own workload
  • Superior communication influencing skills; the ability and credibility to embed and sustain a quality mind set across the organisation and its supply chain
  • Demonstrated flexibility and ability to adapt to changing requirements of a growing company


If you are interested in this opportunity then please send your CV across or contact Bethany on .
Start date
06/2015
From
Real Staffing
Published at
18.05.2015
Project ID:
906433
Contract type
Permanent
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