Manager, Quality Systems Change Mgmt

Job Summary

Change Management and Document Management are processes within the corporate quality system that must follow global regulations to support the TMC business as it grows and changes. The Quality Systems Change Management Manager is responsible for establishing, maintaining, and ensuring the company’s change and document management processes run efficiently and effectively. 

This role will collaborate with key internal business and technical stakeholders and work cross-functionally to improve the overall Terumo (TMC) Change Management and System within the overarching quality system. Core to these activities will be leading the assessment of the scope of change and conducting initial change impact assessments and stakeholder analyses, as well as leading and managing the document control process and the accuracy and integrity of the documentation to comply with all applicable regulations and quality system requirements. The Quality Systems Change Management Manager is responsible for establishing processes and learnings to instill a quality culture at Terumo. 
 

Job Details/Responsibilities

• Manage, mentor, and develop a team of 3-5 professionals. Establish a high-performing team to drive organizational goals and objectives and instill a quality culture. 
• Lead the document control team by overseeing the development of company-wide document control procedures and ensuring company-wide compliance with approved document control processes. Ensure timely processing of document revisions through process improvement and quality metrics. 
• Lead the change management team within the quality system by overseeing the development of company-wide change management procedures and ensuring company-wide compliance with approved change management processes. Oversee the quality change management process within the quality system in alignment with global regulations. Ensure all product and process changes are appropriately evaluated for impact by a cross-functional team. This role will also implement process improvements to facilitate compliance and business efficiency.
• Drive engagement to ensure personnel have clear expectations, appropriate tools, and information, an opportunity to share, grow, and develop, and are recognized for their contributions.
• Develop, support, maintain, and continuously improve the TMC Quality System in accordance with applicable regulations for a global medical device corporation, including, but not limited to, 21 CFR 820, ISO 13485:2016, EU Medical Device Regulation, and MDSAP. 
• Help to streamline the change management and document control processes within the quality system for efficiency, effectiveness, and compliance.
• Utilize process improvement and problem-solving methodologies to improve the quality system continuously. 
• Implement standardized metrics across the organization to monitor our quality system performance. 
• Implement and improve electronic tools to support core quality system processes. 
• Support a proactive and preventive quality systems culture throughout the business.
• Stay abreast of industry and regulatory trends and changes.
• Perform other job-related duties as assigned.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

Quality and business process knowledge

• Extensive experience with FDA, ISO 13485, EU MDR, MDSAP, and global quality system requirements for medical devices.
• Strong analytical skills, including trend and statistical analysis.  
• Ability to use process development tools, e.g., Lean Six Sigma

Leadership skills:

• Demonstrated ability to communicate and interact with all levels of the organization, including Executive Leadership.  
• Strong interpersonal skills to provide coaching, training, and direction. 
• Demonstrated ability to provide clear direction and mentor personnel.   
• Proven experience influencing across the organization to improve products or processes.     

Individual skills required:

• Strong proofreading and writing skills, as well as exemplary attention to detail.
• Demonstrated organizational and prioritization skills. 
• Exceptional decision-making, including the ability to rapidly understand complex changes and pace work completion to the company's needs.
• Demonstrated initiative and ability to work independently while handling multiple tasks.
• Strong computer knowledge (MS Office), technical writing skills and proofreading ability.
• Demonstrated ability to work effectively with cross-functional teams for problem-solving, product, and process improvement is required.
   

Qualifications/ Background Experiences

• A B.S. degree or equivalent in a scientific or engineering discipline is required.
• A minimum of 7 years ' overall experience, with related experience in medical devices/diagnostics, pharmaceuticals, or other regulated industries, is required, focusing on quality systems.
• A minimum of 5 years in a supervisory / management role.  
• Lean Six Sigma certification, e.g., green belt preferred.