Quality Systems Engineer III
Core
Supports global quality systems and acquisition integration for document and records control, ensuring compliance and effective quality system performance across Boston Scientific.
Role type
Quality Systems Engineer
Builds
Compliant information lifecycle management processes and digital quality systems
Domain
Medical device manufacturing / Regulatory Quality
Deliverable
dashboards & analysis
Required skills
ISO 13485, 21 CFR Part 820, EU MDR, CAPA, root cause analysis, risk management, process standardization, system validation, VIP methodology
Preferred skills
None stated
Technologies
None stated
Responsibilities
Execute global process ownership within a governance framework; Support standardization and audit readiness for ISO 13485, 21 CFR Part 820, and EU MDR; Partner with IT on digital platform configuration, enhancements, and validation; Drive continuous improvement using structured methodologies like VIP; Own or contribute to nonconformance, exception, and CAPA activities; Support global quality system projects and acquisition integrations.
Seniority
Mid-level IC