Manager, Quality Systems Change Mgmt

Terumo Medical Corporation - Elkton, MD

Full-time - Manager

Elkton, MD

10,001+ employees

Merchant Wholesalers, Durable Goods

About the position

The Quality Systems Change Management Manager at Terumo Medical Corporation is a pivotal role responsible for overseeing the change management and document management processes within the corporate quality system. This position is essential to ensure that these processes comply with global regulations as the company continues to grow and evolve. The manager will work closely with key internal business and technical stakeholders, collaborating cross-functionally to enhance the overall Change Management System within the quality framework. This includes leading assessments of change scope, conducting initial change impact assessments, and stakeholder analyses. The manager will also oversee the document control process, ensuring the accuracy and integrity of documentation in compliance with applicable regulations and quality system requirements. In this role, the manager will be tasked with establishing processes and fostering a quality culture at Terumo. This involves managing, mentoring, and developing a team of 3-5 professionals to drive organizational goals and instill a commitment to quality. The manager will lead the document control team, ensuring compliance with company-wide document control procedures and timely processing of document revisions through process improvements and quality metrics. Additionally, the manager will oversee the change management team, ensuring that all product and process changes are evaluated for impact by a cross-functional team and that the quality change management process aligns with global regulations. The Quality Systems Change Management Manager will also be responsible for developing, supporting, and continuously improving the TMC Quality System in accordance with applicable regulations for a global medical device corporation. This includes streamlining change management and document control processes for efficiency and compliance, utilizing process improvement methodologies, and implementing standardized metrics to monitor quality system performance. The manager will stay informed about industry and regulatory trends and changes, ensuring that the organization remains proactive in its quality systems culture.

Responsibilities

• Manage, mentor, and develop a team of 3-5 professionals to drive organizational goals and instill a quality culture.
• Lead the document control team by overseeing the development of company-wide document control procedures and ensuring compliance with approved 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 compliance with approved processes.
• Oversee the quality change management process in alignment with global regulations, ensuring all product and process changes are evaluated for impact.
• Drive engagement to ensure personnel have clear expectations, appropriate tools, and recognition for their contributions.
• Develop, support, maintain, and continuously improve the TMC Quality System in accordance with applicable regulations.
• Streamline change management and document control processes for efficiency, effectiveness, and compliance.
• Utilize process improvement and problem-solving methodologies to continuously improve the quality system.
• Implement standardized metrics across the organization to monitor 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.

Requirements

• A B.S. degree or equivalent in a scientific or engineering discipline is required.
• A minimum of 7 years of overall experience in medical devices/diagnostics, pharmaceuticals, or other regulated industries, focusing on quality systems.
• A minimum of 5 years in a supervisory/management role.
• 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.
• Demonstrated ability to communicate and interact with all levels of the organization, including Executive Leadership.
• Strong interpersonal skills to provide coaching, training, and direction.
• Proven experience influencing across the organization to improve products or processes.
• Strong proofreading and writing skills, as well as exemplary attention to detail.
• Demonstrated organizational and prioritization skills.
• Exceptional decision-making skills, including the ability to rapidly understand complex changes.
• Strong computer knowledge (MS Office), technical writing skills, and proofreading ability.

Nice-to-haves

• Lean Six Sigma certification, e.g., green belt preferred.