Sr. Quality Systems Specialist

Terumo Medical   •  

Elkton, MD

Industry: Healthcare


8 - 10 years

Posted 31 days ago

Job Description

Job Summary:
The Sr. Quality Systems Specialist is responsible for ensuring the company’s change management process is running efficiently and effectively. This role will partner with key internal business and technical stakeholders to work cross functionally to improve the overall change management process. Core to these activities will be the ability to effectively manage the portfolio of changes that the organization is pursuing and to foster effective interdepartmental and cross-functional partnerships.

Job Details:
1. Oversee the TMC change management process in alignment with 21 CFR Part 820, ISO 13485 and other global medical device regulations. 2. Write, support and continuously improve policies, processes and procedures required to facilitate compliance and business efficiency. This should be achieved through process improvement and problem solving methodologies. 3. Manage the change management process including a portfolio of projects to ensure they are being managed in a timely and compliant way. 4. Review Change control plans and, as needed, provide guidance, coaching, and other leadership to help change owners and leaders develop optimized change control plans and documentation. 5. Be the Subject Matter Expert for the change control process 6. Own the organization and management of the Change Management Board. 7. Aid in the establishment and/or optimization of effective change control processes and systems. This includes the support in rolling out an electronic change control platform. 8. Establish and maintain change control process metrics. Drive process improvements relative to change control based on the metrics. 9. Provide system training on a regular basis to those involved in the change control process 10. Support the performance of Stewardship reviews of change control documentation and provide actionable summaries to the organization as necessary 11. Support the development of a proactive and preventive quality systems culture throughout the business.


Position Requirements:

Knowledge, Skills and Abilities (KSAs)

  • Quality and business process knowledge:
    • Familiarity with FDA, ISO 13485 and multi-country Quality Systems requirements.
    • Understanding of how the change control process affects, and is affected by, other elements in the Quality Management System
    • Ability to identify and recognize how the change control process potentially affects the wider business of the company
    • Ability to use process development tools (ex. Lean Six Sigma)
    • Ability to apply a practical level of statistics. Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs and user-friendly reports
  • Leadership skills:
    • Demonstrated ability to communicate and interact with all levels of the organization including management
    • Strong interpersonal skills to provide coaching, training, and direction
  • Individual skillsrequired:
    • Strong proofreading and writing skills, as well as exemplary attention to detail
    • Strong organizational and prioritization skills
    • Strong decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.
    • Demonstrated initiative and ability to work independently while handling multiple tasks
    • Strong computer knowledge (MS Office), technical writing skills and proofreading ability
    • Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.

Background Experience

  • B.S. degree or equivalent in Scientific or Engineering discipline required.
  • Minimum 7 years' overall experience with at least 5 years of related experience in Medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on product or production or quality-related responsibilities
  • Previous experienceworking with change management processes for a medical device and/or pharmaceutical company is required.