Quality Management Systems Officer

3 weeks ago


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

The ONE Group Ltd is at the forefront of innovation in the Medical Device sector, driven by a compelling mission to enhance patient outcomes through early disease detection.

As part of a vibrant team of approximately 200 professionals located in a collaborative environment, we are seeking a Quality Assurance Officer to join our Quality team on a 12-18 month Maternity Contract. This role is pivotal to our continued success as we aim for ISO 13485 certification in the near future.

The ideal candidate will thrive in a research and development setting, contributing to our ongoing journey of improvement and 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 with audits conducted by notified bodies and clients.
  • Analyze and report on QMS performance metrics.
  • Provide orientation for new team members regarding Quality protocols.

Qualifications:

  • Comprehensive knowledge of Life Sciences.
  • A minimum of 1-2 years' experience in a similar Quality Assurance role.
  • Certification as a lead auditor (internal).
  • Proven experience in executing the responsibilities listed above.
  • Ability to draft quality procedures effectively.
  • Exceptional presentation and communication skills, with a talent for fostering strong professional relationships.
  • Experience working within a QA team, preferably in the medical devices field.
  • Familiarity with Electronic Document Management Systems.
  • ISO 9001 experience is essential.
  • Familiarity with 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 team environment with a flexible work arrangement, including on-site and remote work options.
  • A friendly and supportive workplace culture that values teamwork.
  • Access to a wellness room on-site.
  • Availability of standing desks.
  • Complimentary lunch provided every Friday.
  • On-site gym facilities.
  • Food trucks offering diverse meal options.
  • Engaging social activities, including unique experiences.


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