Quality Control Analyst

4 weeks ago


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

The ONE Group Ltd is a prominent player in the Medical Device sector, renowned for its commitment to innovation and excellence. We are currently seeking a Quality Assurance Officer to join our dynamic team for a 12-18 month Maternity Cover. This role is pivotal in ensuring the quality and compliance of our products as we strive for ISO 13485 certification.

As part of a vibrant team of approximately 200 professionals, you will contribute significantly to our mission of enhancing patient outcomes through early disease detection.

Key Responsibilities:

  • Oversee all components of the Quality Management System (QMS), including managing Change Controls, Non-conformances, Corrective and Preventive Actions (CAPAs), and 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 protocols.

Qualifications:

  • Comprehensive knowledge of Life Sciences principles.
  • A minimum of 1-2 years of experience in a similar Quality Assurance position.
  • Trained as a lead auditor (internal).
  • Proficient in executing the responsibilities listed above.
  • Experience in drafting quality procedures.
  • Excellent presentation and communication skills, with the ability to foster strong relationships.
  • Background in a QA team, preferably within the medical device industry.
  • 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 beneficial.
  • Eligibility to work in the UK; sponsorship is not available.

Benefits:

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


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