Staff Engineer, Quality Assurance
Core
Provide quality leadership and direction in quality assurance, quality control, and preventive activities within operations and business functions, focusing on continuous improvement of products and processes.
Role type
Staff Quality Engineer (Manufacturing/Regulatory)
Builds
Quality systems, processes, and compliance frameworks for medical device manufacturing
Domain
Medical Devices / Manufacturing / Quality Assurance
Required skills
Root cause analysis, Corrective and Preventive Actions (CAPA), Risk management, Statistical sampling, Audit management, Validation strategies, Supplier relationship management, Lean Six Sigma, Regulatory compliance (ISO 13485, GMP)
Preferred skills
Lean Six Sigma certification, FDA/MoH/TUV interaction experience, Manufacturing transfer experience
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint), Statistical tools
Responsibilities
Lead execution of quality initiatives and projects at local and global levels; Manage internal and supplier-driven Non-Conformances (NCs); Coach the quality team and business functions on quality topics; Interpret KPI trends and drive continuous improvement; Participate in and lead internal and external audits with regulatory representatives; Support manufacturing transfers to other plants/facilities; Manage supplier relationships and ensure timely delivery of quality materials.
Seniority
Staff, hands-on IC with leadership and mentoring responsibilities