Senior Quality Engineer, Global Post Market - Intake

Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At 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. The Senior Quality Engineer provides quality engineering support for manufacturing and product development, helping ensure the delivery of the highest-quality products to our patients. In this role, you will partner with cross-functional teams to improve manufacturing processes, strengthen quality systems and support the development of innovative medical technologies. As a senior technical contributor, you will lead quality initiatives across the product life cycle, influence process improvements and ensure compliance with global regulatory requirements. This position offers the opportunity to make a meaningful impact on patient safety while collaborating with teams across Engineering, Manufacturing, Operations and Quality. Work model, sponsorship: This position follows an on-site work model and requires employees to work from the local Boston Scientific office on a full-time basis. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include: * Provide quality engineering support for manufacturing and new product development to ensure products meet customer, regulatory and business requirements. * Develop and implement product quality plans, product specifications, quality specifications, risk analyses and failure mode and effects analyses (FMEAs) in collaboration with cross-functional product development teams. * Serve as a subject matter expert for the complaint intake process within the global complaint handling system, supporting process execution, continuous improvement and regulatory compliance. * Monitor and evaluate global complaint records from multiple complaint sources and designated reporting locations to ensure timely and accurate event intake. * Lead or support global strategic quality initiatives as a project owner, subject matter expert or cross-functional team member. * Own and participate in nonconformance evaluations and corrective and preventive action (CAPA) activities to drive effective issue resolution and continuous improvement. * Develop quality tools, procedures and training materials that promote consistent application of quality system requirements and best practices. * Evaluate the effectiveness and compliance of quality systems, operations and manufacturing practices against applicable regulations and internal procedures. * Support internal and external audits, including serving as the quality representative during audit activities. * Apply analytical and systematic problem-solving methodologies to identify risks, investigate complex quality issues and implement sustainable solutions. * Partner with cross-functional teams to improve quality, reduce risk and drive operational excellence. * Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Boston Scientific Quality Policy and all documented quality system requirements. Qualifications: Required qualifications: * Minimum of a bachelor's degree in engineering, science or a related technical discipline. * Minimum of 5 years' experience in a regulated manufacturing industry. * Experience supporting quality systems, complaint...