Senior Quality Systems Engineer

Skip to main contentDashboardProfileJoin Talent NetworkSign InEnglishSingle PositionView All JobsSenior Quality Systems EngineerMarlborough US-MA, United States | US-IN-Spencer, US-MA-Marlborough, US-MN-Arden Hills, US-MN-Maple Grove No longer accepting applications.Work ModeHybridRequisition ID631118Additional Location(s): US-MA-Marlborough; US-IN-Spencer; US-MN-Arden Hills; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           About the role:Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.We are seeking a Senior Quality Systems Engineer to serve as a Global Risk Management Process Owner within the Global Quality Systems organization. In this highly collaborative role, you will lead the governance, development and continuous improvement of Boston Scientific's Global Risk Management process to ensure compliance with internal quality standards and global regulatory requirements.The incumbent will be working across divisions and functions, you will partner with design teams, Global Risk Management sub-process stewards and cross-functional stakeholders to establish standardized processes, strengthen risk management practices and drive enterprise-wide consistency. This role provides an opportunity to influence product quality throughout the product lifecycle while advancing continuous improvement initiatives that support innovation, patient safety and regulatory excellence.Work model, sponsorship, relocation:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in their assigned local office at least three days per week. This position may be based in our Arbor Lakes, Arden Hills or Maple Grove, Minnesota; Marlborough, Massachusetts; or Spencer, Indiana. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.Your responsibilities will include:● Serve as the Global Risk Management Process Owner, driving strategic initiatives that strengthen process effectiveness, governance and regulatory compliance.● Develop, maintain and continuously improve global procedures, systems and best practices that support product development and lifecycle risk management.● Partner with Global Risk Management sub-process stewards, design teams and cross-functional stakeholders to ensure consistent implementation of enterprise risk management processes.● Lead Global Communities of Practice to promote collaboration, knowledge sharing, process standardization and adoption of best practices across divisions.● Evaluate trends identified through quality system audits, regulatory submissions, management reviews and quality metrics to identify opportunities for process improvements and corrective actions.● Partner with upstream and downstream process owners to maintain effective integration between Global Risk Management and related quality system processes, including Design Controls, Production and Process Controls, Material Controls and Post Market Surveillance.● Support internal audits, external audits and regulatory inspections by providing documentation, process expertise and audit responses.● Monitor compliance with Global Quality System...