Senior Manager, Design Control & Risk Management

Requisition ID:  31838  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

Provides overall global quality leadership within Terumo BCT to monitor, maintain and continuously improve global processes and supporting technology to ensure successful product launches and compliance to all applicable regulations for Terumo BCT products with respect to Design Controls and Risk Management. The primary responsibility of the position is to lead the global, cross-functional organization to be compliantly effective and organizationally efficient in the use and maintenance of Global Design Controls and Risk Management processes and use of applicable technology.

 

ESSENTIAL DUTIES

• Accountable to maintain the integrity of Global Processes for Design Controls and Risk Management with company, regulatory and professional standards, through monitoring, continuous improvement and implementation of process and applicable supporting technology.
• Communicates on all levels with senior management, including technical, strategic, and business.
• Maintains strong process orientation and drives culture of accountability and continuous improvement mindset.
• Serves as expert for global regulations, standards and processes within area of responsibility.
• Responsible for maintaining and evaluating needs across the organization to ensure global compliance of Design Controls and Risk Management activities with all applicable regulations for Terumo BCT products.
• Responsible for communication and coordination with business functions, global QMS teams and Site Leadership for implementation, auditing, teaching and coaching of process and applicable technology changes.
• Demonstrate strong, influential leadership to effectively manage, resolve and/or escalate QMS-related implementation and/or global interpretation issues in a timely fashion for quick resolution.
• Delivers purposeful, well-organized presentations on changes, issues, resolutions and forward-thinking vision for global Design Controls and Risk management processes and associated supporting technology.
• Effectively works with all Process Owners and QMS Governance leader to ensure a seamless Quality Management System implementation, interpretation and understanding by the Terumo BCT organization.
• Develops and maintains metrics for Design Controls that support the business and management review needs.
• Manages scope and schedule for Design Controls updates and associated training and drives quality, on-time completion for implementation and ongoing changes across the TBCT cross-functional organization.
• Lead Design Control work and utilize influence skills at all levels of the organization; coach, mentor and teach peers and reports as well as successfully teaching and influencing leadership teams towards efficient compliance and assisting with functional excellence approaches.
• Oversees the work of the Design Controls and Risk Management teams.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

​​​​​​​Experience

• Minimum 7 years’ experience in Quality, Regulatory Affairs, Manufacturing or Engineering within regulated industry (e.g. medical device, pharmaceutical).
• Knowledge and experience interpreting and applying global regulations and standards for Quality Management System.
• Demonstrated experience working with, influencing and or leading global teams.
• Experience with FDA inspection and other regulatory/customer audits.
• Knowledge and experience working within a Quality Management System, demonstrated ability to understand and explain the basics of how the Quality Management System works integration of QMS elements and expectations of the organization to meet QMS requirements.

 

Skills

• Demonstrated ability to develop and