Quality Assurance Specialist

3 weeks ago

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

Join a leading Medical Device organization that is dedicated to transforming healthcare through innovative solutions aimed at early disease detection.

As part of a vibrant team of approximately 200 professionals, we are seeking a Quality Assurance Officer to support our Quality Assurance department on a 12-18 month Maternity Cover. This role is crucial as we strive to achieve ISO 13485 certification in the near future.

We are looking for someone who thrives in a research and development environment and is eager to contribute to our ongoing journey towards excellence.

Key Responsibilities:

  • Oversee all elements of the Quality Management System (QMS), including managing change controls, non-conformances, corrective and preventive actions (CAPAs), and handling complaints.
  • Drive continuous improvement initiatives within the QMS and ensure 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 employees regarding quality standards and practices.

Qualifications:

  • Comprehensive knowledge of Life Sciences.
  • A minimum of 1-2 years of experience in a comparable Quality Assurance role.
  • Certification as a lead auditor (internal).
  • Proven experience in executing the responsibilities mentioned above.
  • Ability to draft quality procedures effectively.
  • Excellent presentation and communication skills.
  • Proficient in building strong professional relationships.
  • Experience working within a QA team, preferably in the medical device sector.
  • Familiarity with Electronic Document Management Systems.
  • ISO 9001 experience is essential.
  • Knowledge of ISO 13485, Good Clinical Practice (GCP), 21 CFR Part 820, ISO 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.

Benefits:

  • Comprehensive private medical insurance.
  • Collaborative work environment with a hybrid model of 4 days on-site and 1 day remote.
  • Supportive and friendly workplace culture that fosters teamwork.
  • Access to a wellness room on-site.
  • Availability of standing desks.
  • Complimentary lunch every Friday.
  • On-site gym facilities.
  • Food trucks offering diverse meal options.
  • Engaging social activities, including unique experiences.

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