Quality Systems Manager

3 weeks ago

Elkton, Maryland, United States Terumo Medical Corporation Full time
About the Role

The Quality Systems Manager will lead the establishment, maintenance, and enforcement of the company's change and document management processes to ensure efficiency and effectiveness.

This role will collaborate with key stakeholders to improve the overall Terumo Medical Corporation Change Management and System within the quality system. Core responsibilities include leading the assessment of the scope of change, conducting initial change impact assessments and stakeholder analyses, and leading and managing the document control process.

The successful candidate will establish processes and learnings to instill a quality culture at Terumo Medical Corporation. Key responsibilities include:

  1. Manage, mentor, and develop a team of quality professionals.
  2. Establish a high-performing team to drive organizational goals and objectives and instill a quality culture.
  3. 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.
  4. 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.
  5. Oversee the quality change management process within the quality system in alignment with global regulations.
  6. Ensure all product and process changes are appropriately evaluated for impact by a cross-functional team.
  7. Implement process improvements to facilitate compliance and business efficiency.
  8. 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.
  9. Develop, support, maintain, and continuously improve the TMC Quality System in accordance with applicable regulations for a global medical device corporation.

Requirements:

  1. Quality and business process knowledge.
  2. Extensive experience with FDA, ISO 13485, EU MDR, MDSAP, and global quality system requirements for medical devices.
  3. Strong analytical skills, including trend and statistical analysis.
  4. Ability to use process development tools, e.g., Lean Six Sigma.
  5. Leadership skills: demonstrated ability to communicate and interact with all levels of the organization, including Executive Leadership.
  6. Strong interpersonal skills to provide coaching, training, and direction.
  7. Proven experience influencing across the organization to improve products or processes.
  8. Individual skills required: strong proofreading and writing skills, as well as exemplary attention to detail.
  9. Demonstrated organizational and prioritization skills.
  10. Exceptional decision-making, including the ability to rapidly understand complex changes and pace work completion to the company's needs.
  11. Demonstrated initiative and ability to work independently while handling multiple tasks.
  12. Strong computer knowledge (MS Office), technical writing skills, and proofreading ability.
  13. Demonstrated ability to work effectively with cross-functional teams for problem-solving, product, and process improvement.
  14. A B.S. degree or equivalent in a scientific or engineering discipline is required.
  15. 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.
  16. A minimum of 3 years in a supervisory/management role.
  17. Lean Six Sigma certification, e.g., green belt preferred.

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