Principal Project Management Specialist

Responsibilities may include the following and other duties may be assigned

• Responsible for planning, initiating, monitoring, tracking and/or prioritizing MEIC Quality engineering teams programs and facilitating successful, on-time and within budget execution.
• Sets clear direction and operating mechanisms for ensuring effective monitoring and reporting of performance and safety of commercialized products, ensuring ongoing compliance with regulatory standards.
• Support day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues, identifying project risks and accountability for deliverables across multiple entities.
• Establishes and monitors meaningful metrics for success.
• Responsible for project performance, risk management, administration, financial management, budgeting, capital planning, forecasting and issue resolution.
• Manage communication strategies with MEIC and applicable CST entity stakeholder(s) for appropriate mapping of training needs, knowledge transfers and prioritization of work for sustainable long term growth.
• Support continuous improvement efforts and drive associated change implementation strategies for the product or process being supported.

Required Knowledge and Experience

• Familiarity with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant standards for ensuring compliance to regulatory requirements.
• Ability to collaborate across the matrix - update crossfunctional (and leadership) teams on project status or issues to the organization and providing training on relevant procedures and policies.
• Participating in audits (where applicable) and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator.
• Previous experience working in a cross-functional team environment.
• Develop templates and lead trainings based on quality system regulations, applicable standards and guidance.
• Working knowledge and experience with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
• Good verbal and written communication skills
• Ability to influence others across the organization and/ or locations
• Hands-on experience with Quality Management Systems (Post market surveillance and reporting, complaint analysis, product acceptance and Design/ Change Control)
• Strong written, verbal and project management skills