Job Title: Director Quality Assurance
Job type: Permanent
Location: Oxford, UK (hybrid, travel up to 30%)
A world-leading medical technology company developing innovative solutions are seeking a motivated Director of Quality Assurance to join the team as part of its global expansion. This is an opportunity to work in an innovative, fast-paced global medical device organisation committed to improving patient outcomes.
The Director, Quality Assurance will oversee quality assurance efforts in support of the Quality Management and Oversight (Auditing and KPI Monitoring) Systems, reflecting the core values of innovation, evidence, integrity, teamwork, respect, and a commitment to patient saftey.
This role is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures, training materials, and controls enhancing the performance and quality of products and the company capability to demonstrate conformance to established standards and agency regulations.
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.
- Proactively identify opportunities to apply, continuously improve, and redefine quality assurance systems and controls for all divisional product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
- Proactively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
- Collaborative leadership with all divisional sites to drive proactive quality system improvements.
- Quality Assurance subject matter expert when supporting cross-functional divisional projects Identify Quality Initiatives and lead cross-functional teams to complete them. In coordination with the divisional training function, oversee, develop and provide training to divisional personnel on Quality Assurance topics training Provide diligent and evidence based communication to Executive Management team, peers, and team on Quality Assurance metrics, initiatives and changes Provide guidance, leadership and organizational support for Product Development projects.
Requirements:
- BSc in Bioscience, Biomedical Engineering, Engineering or equivalent or other related field
- 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 for the management of documentation, CAPA, an auditing Quality System elements.
- Deep knowledge of and demonstrated external audit success with International and Domestic regulators, agencies and Notified Bodies.
- Experience in assessing people and building industry-leading people and teams
Please reach out to emily.james@skillsalliance.com for more information or call 02033765104
