Quality Systems Change Management Leader

1 week ago


Elkton, Maryland, United States Terumo Medical Corporation Full time

Position Overview:

The role of the Quality Systems Change Management Manager is crucial in ensuring that Change Management and Document Management processes align with global standards to support the evolving needs of Terumo Medical Corporation (TMC). This position is tasked with the establishment, maintenance, and optimization of the company's change and document management frameworks, ensuring they operate smoothly and effectively.

Key Responsibilities:

  1. Collaborate with key internal stakeholders across various functions to enhance the TMC Change Management and Quality Systems.
  2. Lead the evaluation of change scope and conduct comprehensive change impact assessments and stakeholder analyses.
  3. Oversee the document control process, ensuring accuracy and compliance with all relevant regulations and quality system standards.
  4. Manage and mentor a team of 3-5 professionals, fostering a high-performance culture that aligns with organizational objectives.
  5. Develop and implement company-wide document control procedures, ensuring adherence to approved processes and timely document revisions.
  6. Direct the change management team in establishing and maintaining compliance with change management procedures across the organization.
  7. Facilitate engagement among personnel by providing clear expectations, necessary tools, and recognition for contributions.
  8. Continuously improve the TMC Quality System in accordance with applicable regulations, including 21 CFR 820, ISO 13485:2016, EU Medical Device Regulation, and MDSAP.
  9. Utilize process improvement methodologies to enhance the quality system's efficiency and effectiveness.
  10. Implement standardized metrics to monitor quality system performance and drive improvements.
  11. Stay informed about industry trends and regulatory changes to ensure ongoing compliance.

Qualifications:

  • Bachelor's degree or equivalent in a scientific or engineering discipline.
  • A minimum of 7 years of experience in quality systems within regulated industries, particularly in medical devices or pharmaceuticals.
  • At least 3 years of experience in a supervisory or management capacity.
  • Lean Six Sigma certification (e.g., green belt) is preferred.

Skills and Competencies:

  • In-depth knowledge of FDA regulations, ISO standards, and global quality system requirements.
  • Strong analytical skills, including proficiency in trend analysis and statistical methods.
  • Exceptional leadership and interpersonal skills, with the ability to communicate effectively at all organizational levels.
  • Demonstrated ability to mentor and guide team members while driving organizational improvements.
  • Proficient in technical writing and documentation, with meticulous attention to detail.
  • Strong organizational skills and the ability to prioritize tasks effectively.

In this role, you will play a pivotal part in fostering a proactive quality culture at Terumo, ensuring that our processes not only meet but exceed industry standards.



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