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Academic Quality Specialist

2 months ago


Plymouth, Plymouth, United Kingdom AVD Appoint Full time
Quality Manager Role

AVD Appoint is seeking a Quality Manager to drive the company's quality strategy and ensure compliance with regulatory requirements.

Key Responsibilities:
  • Lead the site quality function and manage the successful delivery of the Quality strategy to achieve corporate goals and objectives.
  • Assure necessary compliance requirements through the Quality Management System, including continuous improvements, CAPA management, document management, quality planning, internal and external audits, validation, risk management, and continuous Quality Management Review.
Requirements:
  • Proven experience in maintaining, updating, and improving Quality Management Systems (QMS).
  • Experience working within the medical device, pharmaceutical industry with ISO13485 knowledge (preferred but also considered for Automotive, Aerospace or ISO9001).
  • Ability to deliver change management and drive cultural transformation.
  • Manage internal audits and host site audits to ensure compliance and quality excellence.
  • Support the delivery of QMS deliverables and contribute to the company's quality objectives.
Desired:
  • Knowledge of applicable regulations and standards related to medical devices internationally (ISO 13485, MDR, MDD, MDSAP).

This is a fantastic opportunity for a Quality Manager to work for a leader within their field, where the work is continuously varied and challenging. If you have the required skills and experience, we would love to hear from you.