Senior Quality Manager - Installation & Servicing (I&S) Quality System Stew at Boston Scientific Corporation Malaysia

Saint Paul, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, Compliance, Process Management, Regulatory Knowledge, Leadership, Collaboration, Continuous Improvement, Data Analysis, Performance Monitoring, Mentoring, Medical Devices, Enterprise Systems, Change Management, Installation Requirements, Servicing Requirements, Global Collaboration

Industry

Medical Equipment Manufacturing

Description

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. 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. 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 and collaborate globally with various leaders to support diverse market needs. Develop and monitor KPIs to measure process compliance and lead continuous improvement actions.