Quality Assurance Manager
3 weeks ago
Position Overview: We are seeking a temporary Quality Assurance Manager to oversee our quality and regulatory obligations. This role is essential for ensuring compliance with industry standards and enhancing our quality management system.
About Qureight Ltd: Based in Cambridge, UK, Qureight Ltd specializes in expediting clinical trial processes through advanced data curation and AI-driven decision-making. Our collaborations with pharmaceutical firms, contract research organizations, and healthcare institutions aim to facilitate the approval of vital medications.
Technological Innovation: Since our inception, we have developed a sophisticated AI technology stack designed for collaborative analysis of imaging, clinical data, and biomarkers. Our proprietary solutions include AI-enhanced image algorithms for CT scans and cloud-based central image reading technologies.
Key Responsibilities:
- Lead the management of the quality management system to ensure compliance with ISO 13485 standards.
- Act as the Person Responsible for Regulatory Compliance (PRRC) in line with EU MDR regulations.
- Oversee all quality and regulatory functions within the organization.
- Support project teams to ensure that all projects meet client expectations and regulatory requirements.
Qualifications:
- A minimum of one year of experience in regulatory affairs or quality management systems related to medical devices.
- Two years of experience in regulatory affairs or quality management systems is preferred.
- Experience in Software as a Medical Device (SaMD) is advantageous.
- Familiarity with the role of PRRC as per EU MDR guidelines.
Management Responsibilities:
- Document processes necessary for the quality management system.
- Report on the effectiveness of the quality management system to senior management.
- Promote awareness of regulatory and quality management requirements across the organization.
Benefits:
- Flexible working hours and hybrid work options.
- Contributory pension scheme.
- 25 days of annual leave plus bank holidays (pro-rata).
- Opportunities for personal and professional development in a dynamic environment.
Join us in our mission to enhance clinical trial efficiency and improve patient outcomes through innovative technology and quality assurance.
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