Quality Assurance Lead

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Qureight Ltd Full time
Position Overview:

We are seeking a temporary Quality Assurance Lead to oversee our quality and regulatory obligations within the organization. This role is essential for ensuring compliance with industry standards and regulations, particularly in the medical device sector.

About Qureight Ltd:

Qureight Ltd is a pioneering company based in Cambridge, UK, dedicated to enhancing clinical trial processes through advanced data management and AI-driven decision-making. Our collaborations with pharmaceutical firms, research organizations, and healthcare institutions aim to streamline data curation, ultimately facilitating the approval of vital medications for patients in need.


Technology and Innovation:

Since our inception in 2018, we have developed a sophisticated AI-powered technology suite designed for collaborative analysis of imaging, clinical data, and biomarkers. Our proprietary solutions include AI-enhanced image algorithms for CT scans and cloud-based technologies that support central image reading.


Key Responsibilities:
  • Act as the Person Responsible for Regulatory Compliance (PRRC) in line with EU regulations.
  • Ensure that the quality management system meets ISO 13485 standards.
  • Oversee all quality and regulatory activities within the organization.
  • Support project teams to align new and existing projects with client expectations.

Essential Qualifications:
  • Proven experience in regulatory affairs or quality management systems related to medical devices.
  • Lead Auditor or Internal Auditor certification in ISO13485.
  • Familiarity with the FDA approval process is advantageous.

Desirable Experience:
  • Experience in Software as a Medical Device (SaMD) is a plus.

Roles and Responsibilities:

As the Quality Assurance Lead, you will be responsible for:

  • Ensuring compliance with the quality management system prior to device release.
  • Maintaining up-to-date technical documentation and EU declarations of conformity.
  • Overseeing post-market surveillance obligations.
  • Reporting on the effectiveness of the quality management system to senior management.

Benefits:
  • Full-time position with flexible working hours.
  • Hybrid working model.
  • Contributory pension scheme.
  • Generous annual leave policy.
  • Opportunities for personal and professional development.

Join us in our mission to transform healthcare through innovative technology and dedicated teamwork.



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