This position will lead a variety of projects in support of the Global Quality QMS Transformation organization as well as other change initiatives for the improvement of Terumo Aortic' s Quality Management System. The ideal candidate will effectively initiate, plan, execute, monitor, and close projects that impact QMS processes, procedures, and practices to continuously meet regulatory and customer requirements. This role will have significant impact across the organization as it is part of the long-term business strategy of Global Standardization and Simplification.
POSITION IN ORGANISATION
KEY DUTIES
Lead QMS transformation projects through the different phases, roadblocks, and timelines.
Act as a change agent for the implementation of best practices across the organization.
delivers the projects within timeline, budget, and expected results.
Establish and maintain project teams, project schedule, deliverables, meetings, and periodic reports to management.
Act in solving problems and influence resolution towards achieving objectives.
Formulate Key Performance Indicators (KPIs) to measure project performance and drive optimal decision making and results.
Develop and maintain a positive relationship with cross-functional team members and leaders.
Present information and periodic updates in a concise and interesting manner to keep team members engaged and projects on track and management informed.
Able to manage conflict and resolve with confidence and expertise.
Train other employees (up, down, and across the organization) on new/revised QMS processes, procedures, and practices
Assess and drive changes to QMS processes, procedures and practices to continuously standardize and simplify following internal documentation and change management processes.
Ensures lessons learned are effectively and efficiently shared with key stakeholders and team members.
Participates in the development and deployment of digital solutions in support of the Quality Management System at the global and site-level.
Able to support other activities and initiatives in support of the Quality Management System and Terumo Aortic' s Global QMS Transformation
Minimum Skills and Capabilities:
Effective leadership skills within a geographically and culturally diverse organization
Demonstrated experience facilitating discussions or workshops.
Ability to interact with all levels within organization.
Effective written and verbal communication skills across multiple formats: formal presentations, meetings, conference calls, e-mails, and memos
Ability to handle multiple projects and tasks simultaneously.
Ability to direct and influence others to work within high quality standards and deliver under rigorous timelines (interpersonal skills)
Organization and time management skills
Results-oriented
Minimum Knowledge & Experience required for the position:
Bachelor's degree in a Life Sciences, Engineering, or relevant discipline.
2-3 years of project management experience or leadership role within the Medical Device regulated industry.
Thorough understanding of Medical Device Quality Management System (QMS) Regulations and Standards (e.g. 21CFR820, EU MDR, ISO 13485)
Certified Project Manager Professional (PMP) is preferred.