Manager, Quality Assurance (Fixed Term - 18 months)
Core
Lead the Quality Assurance team to oversee quality-related activities, ensure regulatory compliance, and drive continuous improvement in manufacturing and operations.
Role type
Manager, Quality Operations
Builds
Medical devices and pharmaceutical products meeting regulatory standards
Domain
Regulated manufacturing (medical device, pharmaceutical, biomedical, automotive)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system compliance, FDA audit support, risk assessment, CAPA management, Six Sigma methodologies, team leadership, regulatory standards knowledge
Preferred skills
MBA or Master's in Engineering/Science, global quality strategy development, cross-functional stakeholder influence, Lean/Six Sigma Black Belt certification
Technologies
Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis, Six Sigma
Responsibilities
Lead QA team and provide technical guidance, partner with site leadership on customer expectations and regulatory requirements, drive quality system compliance and audit readiness, manage nonconforming products and deviations, monitor quality performance indicators, support global quality operations strategies
Seniority
Manager, hands-on leadership
