Job
Description
As a Principal Project Management Specialist, you will be a key member of the Medtronic Quality Engineering team responsible for maintaining the highest standards of product reliability and patient we'll-being across the Cranial and Spinal Technologies (CST) Operating Unit. CST provides a comprehensive portfolio of proven powerful technologies setting the highest standards of integrity and reliability in Cranial and Spinal care. 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
