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Director of Quality

Director of Quality

CT19

An opportunity for a Director of Quality has emerged to join a start-up cancer diagnostics company. You will have the opportunity to build and manage a Quality Department of a growing company with a truly worthwhile mission. Their mission is extending patients’ lives by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. They have a unique technology designed to allow rapid, broad adoption of our assays in testing labs around the world.
The main duties of the Director of Quality are to build and maintain a Quality Management System (QMS) to meet ISO 13485 requirements whilst also taking on Quality Assurance duties for the UK and US sites.

Director of Quality
Location: Remote working with some travel to Cambridge
Salary: Up to £120,000 (DOE) + private medical care + share option scheme + cycle to work scheme + 26 days per year holiday allowance + free physical training sessions
 
Key responsibilities:

  • Delivering and maintaining a QMS for ISO 13485 and US based CLIA/CAP laboratory
  • Promote awareness of applicable regulatory requirements, QMS requirements, and customer requirements throughout the organisation
  • Developing and delivering training across the company 
  • Planning, initiating, and managing quality improvement projects
  • Supporting the product development and software development teams with design control and risk management
  • Supporting investigations and complaint handling
  • Ensuring supplier and subcontractor compliance to requirements
  • Acting as a point of contact with certification authorities, including arranging and planning for assessments
  • Assisting with drafting and compilation of product documentation for regulatory submissions

 
Knowledge, Skills and Abilities:

  • Previous implementation and/or maintenance of an ISO 13485 QMS
  • Knowledge and demonstrated experience with LDTs and IVDs
  • Working knowledge of other applicable standards including 21 CFR 820, 21 CFR Part 11, IEC 62304, ISO 14971, GAMP5, CAP and CLIA
  • Excellent organisational, communication and leadership skills 
  • Results-oriented, with strong attention to detail

Please apply with an up-to-date CV and we will contact you with more information.

Upload your CV/resume or any other relevant file. Max. file size: 78 MB.

Job Overview
Category
Science & Biotechnology
Offered Salary
-
Job Location