Director of Quality Assurance Lead
5 days ago
Skills Alliance is seeking a highly skilled Director of Quality Assurance to join its team. As a key member of the organization, you will be responsible for overseeing quality assurance efforts in support of the Quality Management and Oversight (Auditing and KPI Monitoring) Systems.
The ideal candidate will have a strong background in medical device quality assurance practices, policies, and methods, with experience in managing documentation, CAPA, and auditing quality systems. You will also be responsible for developing and maintaining quality assurance programs, policies, processes, procedures, training materials, and controls.
Key Responsibilities:
- Provide overall Quality Assurance leadership, including setting the vision and direction of the Global Quality Assurance Team
- Direct the activities of the Global Quality Assurance Team
- In collaboration with VP Quality and key stakeholders align annually on workforce planning, budgeting, and talent management
- Architecture and maintenance of the Quality Management System
- Definition and execution of Quality Assurance activities to provide oversight and monitoring of products and services
- Definition and execution of superior Internal and External Audit management processes
- Definition and execution of superior product surveillance activities, including regular and informative reporting on field performance of products
- Offer best-in-class expert guidance and direction of the Quality Assurance Body-of-Knowledge
Requirements:
- BSc in Bioscience, Biomedical Engineering, Engineering, or equivalent
- Demonstrated expert-level knowledge of Medical Device Quality Assurance practices, policies, and methods in support of Class II or III medical devices
- Selection and definition experience with Electronic Quality Management Systems such as MasterControl, Trackwise, EtQ, or others
- Deep knowledge of and demonstrated external audit success with International and Domestic regulators, agencies, and Notified Bodies
Estimated Salary: £80,000 - £100,000 per annum, depending on experience.
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