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An opportunity has arisen to join our Regulatory, Medical and Quality Affairs Department, which is responsible for regulatory compliance, generating technical evidence and maintaining the quality systems required for in vitro device manufacture and sales as a QA Associate.

You will be a senior member of a team responsible for developing, identifying, analysing and improving existing processes to help drive the success of the business Quality Management and possess a desire for continual improvement within a regulated IVD manufacturing environment.

As a key member of the Quality Assurance function, you will also be responsible for the administration of core QMS processes, including document control, change control, customer complaints, non-conforming material, CAPA and training along with QMS performance data gathering & analysis.

 

Your duties will include:

  • Assisting in the generation and maintenance of quality improvement initiative recommendations
  • Annual review and update of the Quality Policy
  • Managing the review, updates and implementation of Quality Objectives
  • Facilitating process design workshops with process experts to determine the implementation of quality objective solutions whilst maintaining compliance
  • Process consolidation of the Oxford & Cambridge site-specific processes into common organisational processes with the goal of a single organisational ISO 13485 certificate
  • Assisting the QMS Process & Improvement Specialist with the implementation of the new eQMS solution and validation of software
  • Define Key Performance Indicators (KPIs) to measure the quality management process effectiveness
  • Management & maintenance of the eQMS
  • Data collection for use in the analysis of the QMS performance
  • Root cause analysis, corrective and preventative action
  • Internal auditing
  • Support with external audits by Notified Bodies, certificate issuers or contract manufacturing customers
  • Supplier controls.

 

What we’re looking for in you:

Essential
  • Degree in a science related subject, biology based or similar discipline or equivalent experience
  • 3–5 years’ experience working in a Quality Assurance role preferably within a regulated industry to ISO 13485 / 9001
  • Experience within a product development, design transfer and manufacturing environment
  • Evidence of a drive for quality management systems continual improvement
  • Evidence of facilitating teams across multiple business functions in root cause analysis and problem solving
  • Confidence with complex processes and problems
  • Excellent communication skills
  • Excellent Computer literacy
  • Project management experience
  • High attention to detail and accuracy.
Desirable
  • Experience in the use of an eQMS
  • Experience of internal auditing
  • Experience in a contract manufacturing environment
  • Experience in project management
  • Experience in root cause analysis
  • Experience in risk management tools
  • Experience in the validation of software used in a quality management system.

 

In return you will receive:

  • Competitive salary
  • Pension Scheme (10% non-contributory)
  • Private Health Insurance
  • 21 days holiday rising with service
  • High Street Discount Scheme.

 

Application is via CV & a one-page covering letter outlining your suitability for the role, salary expectations and notice period

Please note that we will need to establish your right to work in the UK during the recruitment process

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