Principal Quality Systems Engineer - Supplier Controls SFMD

Leading cross-functional project teams across regions, functions, and global stakeholders. Utilizing project management best practices to coordinate activities, communicate progress, collaborate on key deliverables, and meet critical timelines. Driving continuous improvement and globalization by aligning multiple functional departments with BSC and regulatory requirements. Communicating and influencing across the BSC Global Sourcing organization to achieve long-term strategic outcomes. Collaborating with Quality system partners such as regulatory, post-market, and design assurance teams. Providing continuous and rigorous assessment of Material Controls processes and reviewing documentation to ensure compliance with global BSC processes, FDA regulations, ISO 13485, and Regional Medical Device Requirements. Owning highly visible, global, systemic CAPAs while leading through a Community of Practice. Guiding functional members and teams in areas of process ownership, such as supplier audit/AVL, material qualification, procurement, supplier change, and corrective action through audit support and CAPA processes. Determining and tracking actionable material controls metrics and trends to ensure proper execution and effectiveness of the global process. Participating in or leading BSC Communities of Practice to ensure global processes continuously execute at the highest industry/company level and anticipate emerging regulatory lines of questioning. Supporting site, region, and global scale CAPA initiatives, continuous improvement opportunities, and/or projects. Minimum bachelor's degree in an engineering or technical discipline. 7+ years of related work experience (or 5+ years with a relevant master's degree) in the regulated industry, including a demonstrated understanding of QSR and ISO standard requirements for material/purchasing controls, product realization, validation, and CAPA. The ability to work independently, being organized and self-driven. Strong communication skills (both written and verbal) to effectively organize, present, and explain data/information to all internal and external stakeholders. Competency in Microsoft software systems (e.g., MS Excel, PowerPoint, Power BI) and QMS software systems (CAPA, SCAR, etc.). Willingness to travel domestically and internationally up to 15%. Prior experience within a quality function, preferably in supplier quality. Knowledge of Medical Device regulations, specifically Material Controls Quality System requirements. Lead Assessor ISO13485 certification is preferred. Familiarity with drug-coated products is advantageous.