Principal Quality Systems Engineer - Supplier QA

Using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical phase timelines Driving continuous improvement and globalization by gaining alignment across multiple functional departments while meeting BSC and regulation requirements Communicating and Influencing across the BSC Global Sourcing organization to deliver long term strategic outcomes Providing continuous and rigorous assessment of Material Controls processes and review of documentation throughout the material controls processes to ensure compliance with global BSC processes, FDA regulations, ISO 13485, and Medical Device Requirements Ownership of highly visible, global, systemic CAPAs while leading through a Community of Practice Providing guidance to functional members and teams on in area 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 Participates or leads in appropriate BSC Communities of Practice to ensure the global processes continuously executes process outputs at the highest industry/company level and anticipates emerging regulatory lines of questioning. Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects Bachelor's degree and 5+ years or Masters degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment Previous experience in a Supplier Quality, Supplier Engineering, or Sourcing organization Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485 Must be willing to travel 10% of the time Technical writing and documentation skills Degree(s) in Science or Engineering 5+ years of experience in Supplier Quality, Supplier Management, or Quality Systems Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820) Project management skills