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Quality System Consultant

2 months ago

Cambridge UK, Cambridgeshire, United Kingdom Cure Talent Full time

Cure Talent are delighted to be partnered with an exceptional MedTech Start-Up, specialising in the field of Female Health Diagnostics, in their search for an experienced skilled Quality System Consultant to spearhead the implementation of their ISO 13485 Quality Management System.


This is a contract role with the expectation of it being circa 6 months, but with the potential for extension.


You will responsible for developing, implementing and optimising their ISO 13485 QMS. Working closely with the Senior Leadership Team and wide business you will align quality processes with regulatory requirements, enhancing the quality framework and drive continuous improvement.


Key Responsibilities:

  • Develop and implement ISO 13485 compliant quality management system tailored to the business needs.
  • Review and revise existing quality documentation and processes to meet ISO 13485 standards.
  • Provide guidance and training to staff on ISO 13485 requirements and QMS procedures.
  • Identify and address gaps or non-conformities, implementing corrective actions as necessary.
  • Collaborate with various departments to integrate quality management practices into daily operations.


Qualifications:

  • Proven experience as a Quality System Consultant or in a similar role, specifically within the medical device industry.
  • In-depth knowledge of ISO 13485 and related regulatory requirements.
  • Strong track record in building, implementing and managing quality management systems.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and manage multiple priorities effectively.


If you’re a proactive and experienced quality management professional looking to make a significant impact, we’d love to hear from you.