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Job Details

Consultant Name : Aksana Walford
Job : Quality Assurance Consultant
Job Ref : 11552
Location : Cambridge
Salary : 30000-40000
Description :
We are looking for a Quality Assurance Consultant with a technical and quality management system standards relating to device design and development background to join one of the UK's leading product design consultancies.


Responsibilities:

  • General QA support
  • Offering quality and regulatory support across a diverse range of projects requiring compliance to product and technical standards in addition to ISO 9001, ISO 13485 and FDA's QSR.
  • Maintaining up-to-date knowledge and understanding of applicable global (typically EU and US) regulations and appropriate international standards.
  • Providing QA-related advice to project-based colleagues, offering clear and pragmatic solutions.
  • Updating company procedures and processes as required.
  • Undertaking system and project compliance audits.
  • - Process improvement initiatives:
  • Play a key role in the internal development and improvement of our core processes, covering project management, medical device development, non-medical product development, risk management and software development.
  • Maintain awareness of potential changes to international standards and regulations.
  • Manage specific QA responsibilities to enhance company and division-wide activities.
  • Evolve QA processes, by identifying and/or implementing opportunities for improvement.

Requirements:
  • A degree in engineering or the life sciences.
  • A good understanding of the international requirements to ensure compliance with quality management system standards, such as ISO 9001 and ISO 13485. This experience may have been gained in a QA or regulatory position, or in a related, highly associated role.
  • The ability to think creatively, select optimal approaches, encourage change and effectively implement solutions, to work independently.
  • The ability to take ownership of initiatives and deliver results.
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