Head of Quality Assurance
Core
Lead Quality Assurance and Quality Control at a medical device production site, ensuring compliance with international regulations and product safety/efficacy.
Role type
Senior leadership Quality Assurance Manager
Builds
Medical devices (dental implants)
Domain
Medical device manufacturing
Required skills
Quality Management System (QMS) leadership, regulatory compliance (ISO 13485, FDA 21 CFR 820), validation methodologies, risk management (ISO 14971, PFMEA), CAPA management, audit management, cross-functional leadership
Preferred skills
SAP system understanding
Technologies
SAP
Responsibilities
Lead and develop the Quality department, ensure regulatory and QMS awareness, manage process risk assessments, oversee validations and revalidation cycles, assess manufacturing process changes, optimize inspection/testing methods, supervise incoming inspection and final product release, resolve CAPAs, oversee document control and training, act as primary contact for audits
Seniority
Senior, hands-on IC