Director Device Quality

Role: Senior leadership position overseeing quality management for commercial combination products and medical devices, focusing on design transfer, process validation, and post-market activities. Responsibilities: lead quality system initiatives, ensure compliance with global regulations (21 CFR Parts 4, 210, 211, 803, 806, 820; ISO 13485, ISO 14971), develop strategies for no-market support, and foster team growth aligned with company values. Requirements: BS/MS in engineering or related field; 15+ years supporting Quality Engineering of combination products/devices; extensive knowledge of US and international quality standards, design controls, and risk management. Preferred: experience with health authority interactions and influencing regional/global quality policies. High-value specifics: expertise in global GxP and regulatory compliance for combination products and medical devices, leadership in design control and post-market surveillance, and cross-functional stakeholder partnership. Work setup and travel details are not explicitly provided.