QA Officer

Cambridge, UK

Owlstone Medical’s mission is to change the way we currently diagnose and monitor serious disease; our vision is to become the global leader in the non-invasive detection of cancer, infectious disease, and inflammatory disease.

As we develop our technology and detection capability, we are continually evolving the requirements of our Quality Management System within the business. We are therefore looking for a QA Officer to support the Quality Team Lead with the compliance of our QMS – Currently ISO9001:2015, specifically for OML’s diagnostics development.


Key tasks / Accountabilities

  • Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes
  • Work with the Program/Project Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint
  • Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule
  • Perform desk-based, remote and on-site audits of sub-contractors and suppliers
  • Working with other QA staff, provide support to departments, e.g. report review and QA statements, as well as assisting in training of personnel on matters relating to the QMS
  • Maintain thorough knowledge and understanding of ISO standards requirements, regulatory expectations and guidance documents relevant to the work performed within the program
  • Support Quality department initiatives as required, as part of a multi-disciplinary team

Requirements

Essential

  • Planning and Organising
  • Strong presentation, communication and influencing skills
  • Pragmatic with a flexible approach and the ability to deal with changing priorities
  • Ability to work in a dynamic environment


Person Specification

Education and training

  • Degree level qualification within Life Sciences (or equivalent) CPD in relation to Quality, e.g. Quality Auditor, CAPA’s etc


Experience / knowledge

  • Suitable working knowledge within a Pharmaceutical/Medical Device QA department
  • Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards
  • o Essential: ISO 9001,
  • o Desirable: ISO 13485, ISO17025
  • Experience of an Electronic Document Management System


Skills

  • Good inter-personal and communication skills Good organisational and time management skills

Benefits

About Owlstone Medical

Owlstone Medical (www.owlstonemedical.com) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy®. This involves collecting volatile organic compounds (VOCs) and respiratory droplets from breath, which can provide information about metabolic activity and markers related to health and disease.

Breath sampling has substantial advantages for the early detection of disease and to enable precision medicine approaches to patient care. To realize these advantages, Owlstone Medical offers Research Products and Services for biomarker discovery and is developing tests in applications including cancer, liver disease, asthma, and environmental exposure. Our work includes partnerships with major organizations including AstraZeneca, GlaxoSmithKline, the Cleveland Clinic, and the NHS and our platform is in use at well over 100 clinical and academic sites worldwide.

Our leadership in breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical chemists, artificial intelligence specialists and clinical trials coordinators.

The Owlstone group also commercializes a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defense.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit. You will be rewarded with a competitive salary package that includes an Employee share options scheme and private medical insurance and your work will have a clear impact on people’s lives. If you want to experience the buzz of a thriving start-up company set to succeed on a global scale, Owlstone Medical could be the place for you.

We do not accept applications from agencies outside of our preferred supplier list. If you are concerned that your application has not been received by Owlstone Medical, please contact us using careers@owlstone.co.uk.


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Owlstone team members are engineers, scientists and entrepreneurs focussed on changing non-invasive medical technology

We are scientists, doctors, engineers and entrepreneurs on a mission to save lives through early detection and precision medicine

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