Senior Staff Quality Engineer
Core
Provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities for medical devices, focusing on continuous improvement and regulatory compliance.
Role type
Senior Staff Quality Engineer
Builds
Quality systems, processes, and compliance frameworks for endoscopy products
Domain
Medical Devices / Endoscopy / Quality Assurance
Deliverable
product features
Required skills
Quality engineering leadership, Root cause analysis, CAPA management, Regulatory compliance (ISO 13485, GMP, GDP), Risk management, Audit management, Continuous improvement, Problem-solving
Preferred skills
Regulatory agency interaction (FDA, MoH, TUV), Six Sigma (Green/Black Belt), ASQ CQE/CRE certification, Statistics
Responsibilities
Lead quality initiatives and projects, mentor team members, manage NC/CAPA and root-cause investigations, conduct internal/external audits, interpret KPI trends, manage change control and product holds
Seniority
Senior Staff, hands-on IC with leadership/mentorship duties
