Senior Quality Manager - Service Quality Engineering at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

0.0

Posted On

19 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Service Quality, Product Development, Regulatory Compliance, Team Leadership, Quality Systems, CAPA Management, Risk Management, Quality Data Analytics, Service Readiness, Reliability Engineering, Post-Market Surveillance, Lean Six Sigma, Project Management, Collaboration, Technical Excellence

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Act as the primary Quality partner to the Service Development Engineering leadership team, ensuring alignment between service design, field reliability, and regulatory compliance. Collaborate with Divisional Quality, Post Market Quality and Regional Quality teams to share best practices, harmonize approaches, and ensure global consistency. Partner closely with the Sr. Quality Manager - Business Process & I&S Steward to strengthen the integration of product-specific service quality within the broader Installation & Servicing process. Build strong working relationships with leaders across R&D, Manufacturing, Regulatory, Field Service, and Commercial teams to enable quality-driven service innovation. Process Maturity and Continuous Improvement Ensure audit readiness for service-related quality processes and documentation. Lead, coach, and develop a team of 6-8 Service Quality Engineers supporting all BSC divisions and their respective service development projects. Build a high-performing, engaged, and collaborative team culture focused on technical excellence, accountability, and customer-centricity. Define clear priorities, allocate resources, and balance workload across multiple programs and divisions. Drive employee development plans that enhance systems thinking, problem solving, and quality leadership capabilities. Provide quality leadership for service development activities throughout the product lifecycle — from concept through sustaining engineering and post-market support. Ensure service readiness and reliability are considered during product design and transfer, and that service documentation, tools, and processes meet quality standards. Ensure appropriate review and approval of service-related deliverables such as Service Risk Analyses, Service Plans, FRUs, Service CAFs, and Service systems readiness. Support effective management of product field issues, signals, and CAPAs related to service performance. Facilitate data-driven decision-making by linking field performance data to design and service process improvements. Bachelor's in Engineering, Quality, or related technical discipline. Minimum 10 years of experience in Quality Engineering, Service Quality, or Product Development within a regulated industry (medical device preferred). Minimum of 4 years in people leadership roles managing technical teams. Demonstrated success in building and developing high-performing teams. Strong knowledge of Quality Systems (ISO 13485, FDA QSR, ISO 14971). Skilled in CAPA & risk management, and quality data analytics. Master's degree in Engineering, Quality, or related technical discipline. Experience working in Capital Equipment or Operations Quality in Medical Device industry Strong track record of collaboration across global or multi-divisional organizations. Experience with product service readiness, reliability engineering, and post-market surveillance. Skilled in quality data analytics. Proficient in SAP, PLM, or related enterprise quality systems. Lean/Six Sigma or project management certification preferred.

Responsibilities

Act as the primary Quality partner to the Service Development Engineering leadership team, ensuring alignment between service design, field reliability, and regulatory compliance. Lead, coach, and develop a team of Service Quality Engineers supporting all divisions and their respective service development projects.