Quality Assurance Specialist

3 weeks ago

Metropolitan Borough of Solihull, United Kingdom Guerbet Full time

We are a global leader in medical imaging, offering a diverse portfolio of pharmaceuticals, medical devices, digital, and AI solutions for diagnostic and interventional imaging. Our commitment to innovation has driven us for 95 years, with 10% of our revenue dedicated to Research & Development to improve patient diagnosis, prognosis, and quality of life.

Achieve, Cooperate, Care, and Innovate are the core values that guide our daily practices. As a member of our multicultural team of 2,600 people across 20+ countries, you will play a unique role in shaping the future of medical imaging.

Job Purpose:

The Quality Assurance Officer ensures compliance with legislative requirements to maintain our Wholesale License (WDA) by adhering to Good Distribution Practice (GDP). This role manages the UK Quality Management System (QMS) and reports to the Medical Affairs Manager.

  1. Implement and maintain a quality management system.
  2. Focus on managing authorized activities and ensuring record accuracy and quality.
  3. Develop and maintain initial and continuous training programs.
  4. Effectively handle relevant customer complaints.
  5. Perform self-inspections at regular intervals and implement necessary corrective measures.

Quality Management System (QMS)

Manage the local QMS to meet business requirements and align with the corporate QMS where necessary. Lead and document the Management Review process.

Learning Management System (LMS) Administration

Perform local administrative tasks to maintain UK users and training on the Company LMS: ComplianceWire.

  1. Ensure correct creation and maintenance of UK users and training items.
  2. Liaise with the global LMS manager over arising issues and training.

Implement a local EMS that meets ISO14001 standards.

Information Security Management System (ISMS)
Implement a local ISMS that meets ISO27001 standards.

Additional Responsibilities

Regulatory Affairs

  1. Manage company medical device products on the Medical Device Register.
  2. Support Medical Affairs Manager and Corporate RA with arising issues.
  3. Good competencies in contrast media and medical devices are an asset.
  4. Fluent in English. Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position, please send an email to.

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