Quality Assurance System Specialist

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Cure Talent Full time
Position Overview

Cure Talent is excited to collaborate with a pioneering MedTech Start-Up focused on Female Health Diagnostics. We are seeking a knowledgeable and skilled Quality System Consultant to lead the establishment of their ISO 13485 Quality Management System.

This role is structured as a contract, anticipated to last approximately 6 months, with opportunities for extension based on project needs.

The successful candidate will be tasked with the development, implementation, and enhancement of the ISO 13485 Quality Management System. Working in close partnership with the Senior Leadership Team and various departments, you will ensure that quality processes align with regulatory standards, thereby improving the overall quality framework and fostering continuous improvement.

Key Responsibilities:

  • Design and execute a quality management system that complies with ISO 13485, tailored to the specific needs of the organization.
  • Assess and update existing quality documentation and processes to ensure compliance with ISO 13485 standards.
  • Offer training and support to team members regarding ISO 13485 standards and quality management system procedures.
  • Identify and rectify gaps or non-conformities, implementing necessary corrective actions.
  • Work collaboratively with different departments to embed quality management practices into everyday operations.

Qualifications:

  • Demonstrated experience as a Quality System Consultant or in a comparable role within the medical device sector.
  • Comprehensive understanding of ISO 13485 and associated regulatory requirements.
  • Proven success in developing, implementing, and managing quality management systems.
  • Exceptional communication and interpersonal abilities.
  • Capacity to work autonomously and effectively manage multiple priorities.

If you are a proactive quality management professional eager to make a meaningful contribution, we would be pleased to hear from you.

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