Sr. Quality Engineer II / Sr. Quality Specialist II

Role: Senior Quality Engineer or Specialist supporting manufacturing and quality of ophthalmic combination products (pharmaceutical and medical device). Objectives: ensure compliance, facilitate product transfers, lead risk management, and drive continuous quality improvement. Responsibilities: oversee GMP compliance, support product validation, manage CAPAs, author deviation reviews, and lead audits; collaborate with R&D, operations, clinical, and regulatory teams to bring and maintain products on market. Requirements: Bachelor’s in Engineering, Science, or related field; 8+ years of relevant experience (pharmaceutical focus preferred), including QC analytical validation and stability programs; strong knowledge of 21 CFR Parts 210/211, 820, ISO 13485, USP, ICH. Preferred: ASQ certifications (CQE, CQA, CBA). HighValue: combination products, ophthalmic devices, GMP, regulatory compliance, GxP, validation, risk management. WorkSetup: not specified; likely on-site or hybrid given manufacturing context.