Senior Quality Engineer - Combination Product

Skip to main contentDashboardProfileJoin Talent NetworkSign InEnglishSingle PositionView All JobsSenior Quality Engineer - Combination ProductArden Hills US-MN, United States | N/AApply NowAdd to cartFind out how well you match with this jobUpload your resumeJob descriptionCompany and benefitsWork ModeOnsiteRequisition ID619126Additional Location(s):  N/ADiversity - 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.At this time, we are seeking a Senior Quality Engineer to support the manufacturing of combination products. In this role, you will partner with Operations and Product Development teams to ensure compliance with current Good Manufacturing Practice (cGMP) requirements for combination products while delivering innovative, high-quality drug-device combination therapies for patients.This position directly supports the Arden Hills Operations business unit manufacturing Urology combination products and offers opportunities to collaborate across additional business units, product portfolios, and divisions.Work model, sponsorship, relocation:At Boston Scientific, we value collaboration and innovation. This position follows an on-site work model and requires employees to work from the Arden Hills facility five days per week.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:● Lead compliance and continuous improvement initiatives supporting the manufacture of combination products in accordance with 21 CFR Part 4.● Serve as the technical quality lead during internal and external audits related to combination product compliance.● Analyze quality data to identify trends, drive continuous improvement initiatives, and implement effective corrective and preventive actions.● Develop quality tools and training materials while effectively communicating requirements across a broad range of organizational skill levels.● Lead cross-functional teams to reduce manufacturing defects, including scrap, nonconforming product and customer complaints, through root cause analysis and corrective actions.● Support product containment activities, including product stops and release criteria documentation, as required.● Develop and implement product quality plans, specifications, risk analyses and Failure Modes and Effects Analyses (FMEAs) in partnership with Product Development and Manufacturing teams.● Develop process monitoring systems by identifying critical manufacturing process steps, reducing process variation and improving process capability.● Collect, analyze and interpret manufacturing quality metrics to support sustaining product improvements and new product development initiatives.● Evaluate the effectiveness and compliance of quality systems, manufacturing operations and business practices against applicable regulations and internal procedures.● Perform internal quality audits, as assigned, and support continuous improvement of the Boston Scientific Quality System.Required qualifications:● Minimum Bachelor's degree in Chemical Engineering, Chemistry or a related scientific or engineering discipline.● Minimum of...