Quality Sys Engineer III
Core
Provide technical leadership and subject matter expertise in the development, maintenance, and continuous improvement of the Quality Management System (QMS) to ensure regulatory compliance and support high-quality medical technologies.
Role type
Senior Quality Systems Engineer
Builds
Quality Management System (QMS) processes, documentation, and compliance frameworks
Domain
Medical Devices / Regulatory Quality
Required skills
QMS process management, CAPA, root cause analysis, audit preparation, regulatory compliance, risk-based decision-making, data analysis, procedure development, stakeholder collaboration, technical mentorship
Responsibilities
Lead and support QMS processes including CAPA, nonconforming events, internal and external audits, and management review; Ensure compliance with FDA QMSR, ISO 13485, and ISO 14971; Provide technical guidance and mentorship on complex investigations and effectiveness verification; Support internal and external audits and regulatory inspections; Analyze quality metrics and trends to identify systemic risks; Lead continuous improvement initiatives to enhance QMS effectiveness; Collaborate with cross-functional teams to resolve quality issues; Develop and maintain quality procedures and controlled documentation; Apply risk-based decision-making to quality and compliance issues; Serve as a QMS subject matter expert providing training; Lead quality system projects and partner with global teams for continuous improvement.
