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Quality Systems Change Management Lead

2 months ago

Elkton, Maryland, United States Terumo Medical Corporation Full time

Position Overview:

The role of the Quality Systems Change Management Manager is pivotal in ensuring that Change Management and Document Management processes adhere to global standards, facilitating the growth and evolution of Terumo Medical Corporation (TMC). This position is tasked with the establishment, maintenance, and optimization of the company's change and document management frameworks to ensure they operate with maximum efficiency and effectiveness.

Key Responsibilities:

  • Lead and mentor a dedicated team of 3-5 professionals, fostering a high-performance culture aligned with organizational objectives.
  • Oversee the document control team, ensuring the development and adherence to company-wide document control protocols, while driving compliance with established processes.
  • Manage the change management team, guiding the creation of comprehensive change management procedures and ensuring alignment with global regulatory standards.
  • Conduct thorough assessments of product and process changes, collaborating with cross-functional teams to evaluate impacts effectively.
  • Enhance engagement by providing team members with clear expectations, necessary tools, and recognition for their contributions.
  • Continuously develop and refine the TMC Quality System in compliance with relevant regulations, including 21 CFR 820, ISO 13485:2016, EU Medical Device Regulation, and MDSAP.
  • Streamline change management and document control processes to promote efficiency and compliance.
  • Utilize process improvement methodologies to foster ongoing enhancements within the quality system.
  • Implement standardized metrics to monitor and assess the performance of the quality system.
  • Enhance electronic tools to support essential quality system processes.
  • Promote a proactive quality culture throughout the organization.
  • Stay informed on industry trends and regulatory changes to ensure compliance and best practices.
  • Perform additional responsibilities as required.

Qualifications:

  • Strong knowledge of quality and business processes.
  • Extensive experience with FDA regulations, ISO 13485, EU MDR, MDSAP, and global quality system standards for medical devices.
  • Proficient analytical skills, including trend analysis and statistical evaluation.
  • Ability to apply process development tools, such as Lean Six Sigma.
  • Demonstrated leadership capabilities, with effective communication skills across all organizational levels.
  • Strong interpersonal skills for coaching, training, and providing direction.
  • Proven track record of influencing organizational improvements in products or processes.
  • Exceptional writing and proofreading skills, with a keen attention to detail.
  • Strong organizational and prioritization abilities.
  • Excellent decision-making skills, with the capacity to navigate complex changes efficiently.
  • Ability to work independently while managing multiple priorities.
  • Proficient in MS Office and technical writing.
  • Experience collaborating with cross-functional teams for problem-solving and process enhancement.

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 such as medical devices, diagnostics, or pharmaceuticals, with a focus on quality systems. A minimum of 3 years in a supervisory or management capacity is also required. Lean Six Sigma certification, such as a green belt, is preferred.