Senior Quality Manager - Installation & Servicing; I&S Quality System Steward

Senior Quality Manager - Installation & Servicing (I&S) Quality System Steward

Onsite Location(s):
Arden Hills, MN, US, 55112

Additional Location(s): N/A

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.

Boston Scientific is seeking a Senior Quality Manager – Installation & Servicing (I&S) Quality System Steward to lead the global governance, compliance, and continuous improvement of our Quality System processes related to installation and servicing of our capital equipment products. In this high-impact role, you will serve as the Quality process owner and subject matter expert for I&S within the Boston Scientific Quality System.

You will ensure these processes remain compliant with evolving global regulations, connected to other quality system elements, and supported by well-designed processes, digital tools and systems. You’ll lead a team of Business Process Engineers dedicated to designing and maintaining effective, compliant, and efficient processes that support our global service and commercial teams. You will partner closely with Service teams globally to ensure Boston Scientific’s global I&S framework continues to enable safe, effective, and customer-focused service operations.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Serve as the Global Process Steward for Installation & Servicing within the Quality System—owning the design, documentation, and continuous improvement of associated procedures, standards, and tools.
• Ensure I&S processes comply with global regulatory requirements (FDA QSR, ISO 13485, ISO 14971, EU MDR) and remain integrated with other key Quality System processes.
• Collaborate globally with Commercial, Service, and Quality leaders to understand regional models, customer needs, and operational challenges, ensuring processes and systems evolve to support diverse market needs.
• Partner with IT and Digital Quality teams to ensure supporting systems (ERP, PLM, and Field Service platforms) are compliant, validated, and optimized for efficiency and data integrity.
• Lead global initiatives to standardize, simplify, and digitize service-related quality processes that enhance compliance and business performance.
• Act as the Subject Matter Expert (SME) for I&S in internal, corporate, and external regulatory audits.
• Develop and monitor key performance indicators (KPIs) to measure process compliance, effectiveness, and efficiency; lead management reviews and implement continuous improvement actions.
• Manage and mentor a global team of Business Process Engineers, fostering technical and leadership growth.
• Engage externally in industry and standards forums to represent Boston Scientific, influence evolving regulations and guidance, and bring industry best practices into our Quality System.
• Build strong, collaborative relationships across Boston Scientific’s global Quality, Service, Commercial, Regulatory, and R&D teams to ensure alignment and process excellence.

• Bachelor’s degree in Engineering, Science or related technical discipline
• Minimum of 8 years of experience in Quality Systems, Compliance, or Process Management within a regulated industry (medical device preferred).
• Minimum of 3 years of people leader experience
• Demonstrated success serving as a regulatory or process SME during audits and inspections.
• Knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, and EU MDR.

• Master’s degree in Engineering, Science or related technical…