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Quality Assurance System Specialist

2 months ago

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

Cure Talent is excited to collaborate with a leading 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 QMS. You will work closely with the Senior Leadership Team and various departments to ensure that quality processes align with regulatory standards, thereby strengthening the quality framework and fostering continuous improvement.

Key Responsibilities:

  • Design and execute a quality management system compliant with ISO 13485, tailored to the specific needs of the organization.
  • Assess and update existing quality documentation and processes to ensure alignment with ISO 13485 standards.
  • Deliver training and support to personnel regarding ISO 13485 requirements and QMS protocols.
  • Identify gaps or non-conformities and implement corrective actions as required.
  • Engage with multiple departments to weave 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 frameworks.
  • Proven history of developing, implementing, and overseeing quality management systems.
  • Exceptional communication and interpersonal abilities.
  • Capacity to work autonomously and effectively manage various priorities.

If you are a dedicated and experienced quality management professional eager to make a meaningful contribution, we encourage you to consider this opportunity.