Regional Lead Quality Engineer

Role: Lead quality engineer overseeing compliance for CSL's combination product development activities, ensuring adherence to 21 CFR Part 4, FDA, MDR, ISO, and global standards throughout the product lifecycle. Responsibilities: guide and oversee design control processes, collaborate with internal teams and external vendors, ensure regulatory compliance, support vendor audits, and manage quality systems and documentation. Requires providing risk analysis, statistical methods, and process improvements. Qualifications: bachelor’s in biomedical, mechanical, or related engineering; minimum 5 years in medical device or combination product quality, R&D, or manufacturing; strong regulatory knowledge (21 CFR 820, ISO 13485, ISO 14971, EU MDR); experience with design controls, risk management, V&V, and human factors. Preferred: experience with drug-delivery combination products, embedded software, connected health solutions. HighValue: medical devices, combination products, regulatory compliance, design control, risk management, vendor oversight, global standards, travel required. WorkSetup: periodic domestic and international travel.