Medical Device Quality Manager

6 days ago


Cambridge, Cambridgeshire, United Kingdom Cure Talent Full time

Job Opportunity

Cure Talent is partnering with a pioneering MedTech Start-Up specializing in Female Health Diagnostics to find an experienced Quality System Consultant.

This is a contract role with the potential for extension, expected to last around 6 months.

Key Responsibilities:

  • Develop and implement a tailored ISO 13485 compliant quality management system aligned with 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.

Requirements:

  • 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.

About the Role:

This is an exceptional opportunity for a proactive and experienced quality management professional to make a significant impact in the medical device industry.



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