QA Compliance Officer

3 weeks ago


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

Join a pioneering organization in the Medical Device sector, dedicated to transforming healthcare through innovative solutions aimed at early disease detection.

As part of a vibrant team located in a collaborative environment, we are seeking a Quality Assurance Officer to contribute significantly to our mission. This role is essential as we strive for compliance with ISO 13485 standards.

Key Responsibilities:

  • Oversee the Quality Management System (QMS), including managing Change Controls, Non-conformances, CAPAs, and Complaints.
  • Drive continuous improvement initiatives within the QMS and ensure adherence to 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:

  • In-depth knowledge of Life Sciences.
  • A minimum of 1-2 years of experience in a Quality Assurance capacity.
  • Certification as a trained lead auditor (internal).
  • Proven experience in executing the responsibilities listed above.
  • Ability to draft quality procedures effectively.
  • Exceptional presentation and communication skills.
  • Capability to foster 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.
  • Knowledge of ISO 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.

Benefits:

  • Comprehensive private medical insurance.
  • Collaborative work environment with a hybrid model of on-site and remote work.
  • Supportive and friendly workplace culture.
  • Access to wellness facilities.
  • Standing desks available for ergonomic support.
  • Complimentary lunch every Friday.
  • On-site gym facilities.
  • Food truck offerings.
  • Engaging social events and activities.


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