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Quality Manager (Life Sciences)

Oxford, UK

The Role

We’re looking for an innovative Life Science Quality Manager to lead our new Life Science Quality Assurance Team. Working closely with our Medical Device Quality Manager and Information Security Manager you will be responsible for ensuring that our service provision complies with ISO 13485: 2016, ISO 27001: 2013, ISO 9001: 2015 and other relevant standards. You will work with our service teams to find ways for continual improvement. A good sense of humour and positive attitude is vital.

Next year we are planning on opening up a service office in the US, so this role may involve occasional travel. The growing company also provides plenty of opportunities for career progression.

Responsibilities

  • Lead and develop a team of Life Science Quality Engineers to achieve business objectives
  • Alongside the Medical Devices Quality Manager, manage and maintain the Integrated Management System
  • Alongside the Medical Devices Quality Manager, manage the Internal and External audit schedule, assisting with Internal audits where required
  • Initial point of contact for quality guidance and support for the service provision team
  • Manage / assist with the Life Science Quality teams budget / headcount
  • Work alongside cross-functional project teams representing the Life Science Quality Team to ensure compliance to ISO regulations
  • Work with the service department managers to ensure best practice and to drive continuous improvement
  • Contribute to reducing potential product and service Project risks
  • Participate in Handling Boards where required
  • Assist with the tracking and closure of actions arising from Internal / External audits
  • Deputise for the Chief Quality and Regulatory Compliance Officer (CQRCO) where required

Skills and requirements: Essential

  • Experience in a clinical trials or medical service delivery environment
  • Sound knowledge of software development principles
  • Excellent analytical and problem-solving skills
  • Strong leader who is not afraid to be hands-on

Skills and requirements: Desirable

  • Degree or equivalent qualification in Life Sciences
  • Experience of ISO 13485: 2016, ISO 27001: 2013 and ISO 9001: 2015
  • Certified Lead Auditor, preferably ISO 13485

Interested in this position?

We are always looking for brilliant people to join us here at Perspectum Diagnostics.

Use the form below to send us your application.