Director, Quality Assurance, Manufacturing
Core
Develop, implement, and direct quality assurance policies and procedures to evaluate and improve the quality of complex medical devices and pharmaceutical products, ensuring compliance with global regulatory standards.
Role type
Director, Quality Assurance (Manufacturing)
Builds
Quality Management Systems for multiple manufacturing entities and suppliers
Domain
Medical Devices and Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 9001/13485 certification maintenance, MDSAP compliance, FDA Quality Management System Regulation, European Medical Device Regulation (MDR) 2017/745, supplier quality audit leadership, CAPA management, regulatory correspondence, PRRC responsibilities, process and product transfer project leadership
Preferred skills
Master's degree in Engineering or Science, RAPS certification, ASQ certification, experience managing QMS for multiple manufacturing locations
Technologies
ISO 9001, ISO 13485, MDSAP, FDA QMSR, MDR 2017/745
Responsibilities
Direct all phases of highly technical quality assurance audit activities; Oversee Quality Management Systems of multiple entities ensuring compliance with global MDSAP requirements; Lead in the monitoring of supplier performance efforts and recommend changes to improve the production process; Serve as FDA Official Correspondent for US Facilities and US Agent for foreign HS entities; Serve as Person Responsible for Regulatory Compliance (PRRC) at manufacturing locations; Assess the effectiveness of existing policies, guidelines and procedures and recommend changes
Seniority
Director, strategic leadership and team development
