Terumo Medical Corporation - Elkton, MD
posted about 2 months ago
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.