Boston Scientific · 2 months ago
Senior Quality Manager - Installation & Servicing (I&S) Quality System Steward
Arden Hills, MN
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expBoston Scientific is a leader in medical science committed to advancing science for life. They are seeking a Senior Quality Manager – Installation & Servicing (I&S) Quality System Steward to lead the governance, compliance, and continuous improvement of Quality System processes related to the installation and servicing of capital equipment products.
Health CareMedicalMedical Device
No H1B
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
Variable compensation governed by the Sales Incentive Compensation Plan
Core and optional benefits offered at BSC
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-22
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