Senior Manager, Quality Engineering

Role: Lead the Quality Engineering team at Solta Medical, focusing on developing and maintaining compliant quality systems aligned with FDA, ISO, and international standards. Responsibilities: manage talent recruitment and development, foster a culture of quality, support regulatory audits and inspections, drive process validation and improvement projects, and oversee non-conformance and risk management activities. Collaborate with R&D, Operations, and other functions to resolve quality issues and ensure continuous improvement. Qualifications: Bachelor's degree in sciences or a technical field; at least 7 years in the medical device industry with 5+ years of management experience. Extensive knowledge of FDA QSR, ISO 13485, MDR, and related regulations; experience with CAPA, supplier management, and risk management (ISO 14971). Skills: strong leadership, collaboration, negotiation, and conflict resolution; excellent communication, analytical, and problem-solving abilities. High-value biopharma specifics: medical device industry, quality systems compliance, regulatory inspections, GxP environment, and supplier oversight. Work setup: primarily office-based with limited travel (~0-10%).