Quality Systems Change Management Manager

3 weeks ago


Elkton, Maryland, United States Terumo Medical Corporation Full time

Job Summary

Terumo Medical Corporation is seeking a Quality Systems Change Management Manager to establish, maintain, and ensure 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.

Key Responsibilities

  • Manage, mentor, and develop a team of 3-5 professionals 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.
  • 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.
  • 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.

Requirements

  • 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.

Terumo Medical Corporation is an Equal Opportunity Employer

We value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.



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