Regulatory Affairs Quality Officer

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom The ONE Group Ltd Full time

The ONE Group Ltd is a distinguished player in the Medical Device sector, known for its compelling mission to enhance healthcare through innovative solutions.

As part of a vibrant team located in a collaborative environment, we are seeking a Quality Assurance Officer to join our Quality team on a temporary contract. This role is crucial as we aim for compliance with ISO 13485 standards.

In this position, you will work closely with the QA Manager to:

  • Oversee the Quality Management System (QMS), ensuring effective management of Change Controls, Non-conformances, CAPAs, and Complaints.
  • Drive continuous improvement initiatives within the QMS and uphold compliance through regular internal audits.
  • Assist during audits conducted by notified bodies and clients.
  • Analyze and report on QMS performance metrics.
  • Facilitate the onboarding process for new team members regarding Quality protocols.

Qualifications required:

  • Comprehensive knowledge of Life Sciences.
  • A minimum of 1-2 years' experience in a QA role.
  • Certification as a trained lead auditor (internal).
  • Proven experience in executing the responsibilities listed above.
  • Ability to draft quality procedures effectively.
  • Excellent presentation and communication skills, with a knack for building strong relationships.
  • Experience within a QA team, preferably in the medical devices field.
  • Familiarity with Electronic Document Management Systems.
  • ISO 9001 experience is essential.
  • Knowledge of 13485, GCP, 21CFR Part 820, 17025, and Clinical Trials is advantageous.
  • Experience as a lead external auditor is highly desirable.
  • Eligibility to work in the UK is required; sponsorship is not available.

What we offer:

  • Comprehensive private medical insurance.
  • A collaborative work environment with a flexible schedule of 4 days on-site and 1 day remote.
  • A friendly and relaxed workplace culture that fosters team spirit.
  • Access to a wellness room on-site.
  • Standing desks and gym facilities available.
  • Complimentary lunch every Friday.
  • Food trucks and engaging social activities.

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