Quality Systems Change Management Leader

2 months ago


Elkton, Maryland, United States Terumo Medical Corporation Full time

Position Overview:

The Quality Systems Change Management Manager plays a crucial role in overseeing the processes of Change Management and Document Management within the corporate quality framework. This position is essential for ensuring compliance with global regulations as the Terumo Medical Corporation (TMC) evolves and expands.

Key Responsibilities:

  1. Establish and uphold efficient change and document management processes that align with the company's quality system.
  2. Collaborate with internal stakeholders across various departments to enhance the overall Change Management System.
  3. Lead the evaluation of change scopes and conduct initial impact assessments and stakeholder analyses.
  4. Manage the document control process, ensuring the accuracy and integrity of documentation in compliance with relevant regulations.
  5. Foster a quality-centric culture within TMC by implementing effective processes and learnings.

Team Leadership:

Oversee and mentor a team of 3-5 professionals, promoting high performance to achieve organizational objectives and instill a culture of quality.

Document Control Management:

Direct the document control team to develop and maintain company-wide procedures, ensuring compliance with established processes and timely processing of document revisions.

Change Management Oversight:

Lead the change management team to create and enforce company-wide procedures, ensuring adherence to global regulations and proper evaluation of product and process changes.

Engagement and Development:

Encourage team engagement by providing clear expectations, necessary tools, and opportunities for professional growth and recognition.

Continuous Improvement:

Support the ongoing enhancement of the TMC Quality System in accordance with applicable regulations, including 21 CFR 820, ISO 13485:2016, EU Medical Device Regulation, and MDSAP.

Utilize process improvement methodologies to streamline change management and document control processes for greater efficiency and compliance.

Performance Monitoring:

Implement standardized metrics to assess the performance of the quality system and improve electronic tools to support core processes.

Industry Awareness:

Stay informed about industry trends and regulatory changes to ensure the company remains compliant and competitive.

Qualifications:

Knowledge, Skills, and Abilities:

  • In-depth understanding of quality and business processes.
  • Extensive experience with FDA regulations, ISO 13485, EU MDR, MDSAP, and global quality system standards for medical devices.
  • Strong analytical capabilities, including statistical analysis and trend evaluation.
  • Proficiency in process development tools, such as Lean Six Sigma.
  • Exceptional leadership and communication skills, capable of engaging with all organizational levels.

Educational Background:

A Bachelor’s degree or equivalent in a scientific or engineering discipline is required, along with a minimum of 7 years of relevant experience in regulated industries, particularly in medical devices or pharmaceuticals, and at least 3 years in a supervisory role. Lean Six Sigma certification (green belt preferred) is also advantageous.



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