Head of Quality Assurance
Core
Lead the Quality department to ensure manufacturing site compliance with international medical device regulations and maintain the Quality Management System (QMS) for product safety and efficacy.
Role type
Head of Quality Assurance (Manufacturing)
Builds
Medical devices (dental implants and related products)
Domain
Medical device manufacturing / Regulated process industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) leadership, validation methodologies (process, software, sterilization), risk management (ISO 14971, PFMEA), regulatory compliance (ISO 13485, FDA 21 CFR 820), CAPA management, audit management, cross-functional leadership
Preferred skills
SAP system understanding
Technologies
SAP
Responsibilities
Lead and develop the Quality department (QC and QA), ensure robust validations and monitoring activities, oversee incoming inspection and final product release, manage Corrective and Preventive Actions (CAPA), act as primary contact for internal and external audits
Seniority
Senior, hands-on IC with management responsibilities