Sr Mgr, QA/Quality Engineer, Device & Combination Products

Role: Senior Manager/Quality Engineer leading QA/QE for device and combination products, ensuring compliance, quality, and regulatory readiness of drug substance, drug product, and device components in a remote setting. Responsibilities: provide technical leadership to external suppliers and internal teams; review and approve manufacturing and stability data; oversee regulatory compliance (21 CFR Parts 4, 210/211, ISO 13485, ISO 14971); support supplier qualification, audits, and inspections; lead investigations, CAPAs, change controls, and risk assessments; and collaborate on cross-functional projects supporting development and commercial supply. Qualifications: Bachelor's in Chemistry, Biology, Engineering, or related; 8+ years in Quality Assurance/Engineering within medical devices or drug-device combination products; experience with GxP, regulatory audits, and managing CDMOs; strong knowledge of cGMPs, ISO standards, and combination product regulations. Preferred: experience with ISO 13485-aligned systems, EU MDR, combination delivery systems, regulatory submissions, data integrity, electronic QMS, and lifecycle management of device records. Work setup: fully remote within US; travel up to 25% domestically and internationally.