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

Boston Scientific • Arden Hills, MN

4h

About The Position

Your responsibilities will include: 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. 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.

Requirements

• Bachelors 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

Nice To Haves

• Masters degree in Engineering, Science or related technical discipline
• Proven success leading global quality or process management teams and influencing across functions
• Deep understanding of installation and servicing requirements for medical devices
• Experience working across multiple commercial regions with diverse business models and service operations
• Experience with enterprise systems such as SAP, PLM, and Field Service Management platforms
• Proven ability to influence externally through participation in industry forums, standards development, and professional networks
• Exceptional leadership, collaboration, and change management capabilities
• Strong analytical ability to monitor and improve process performance through data-driven insights

Responsibilities

• Ensure I&S processes comply with global regulatory requirements (FDA QSR, ISO 13485, ISO 14971, EU MDR)
• Collaborate globally with Commercial, Service, and Quality leaders to understand regional models, customer needs, and operational challenges
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees