At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

www.terumoaortic.com

Position Summary

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.

Key Accountabilities:

• 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.
• Take action 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

Budget managed (if applicable)

No.

Internal Networking/Key relationships

This position requires cooperating with different departments across the global organization, such as Quality, IT, Engineering, R&D, Regulatory, Operations, Finance, and HR.

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.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.