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.
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.
Knowledge, Skills and Abilities (KSAs)