Associate Quality Engineer, Combination Products

Role: Associate Quality Engineer supporting global quality activities for CSL Behring's combination products and medical devices. Responsibilities: serve as QA representative on development projects, participate in Design Control, risk management, document reviews, verification/validation, and change management; oversee external vendor quality and development activities; support maintenance and continuous improvement of quality systems; assist with investigations, CAPAs, nonconformance, and audits; ensure compliance with FDA, EU MDR, and other standards; maintain quality documentation and databases. Requirements: Bachelor’s in mechanical, biomedical engineering, or related field; 3+ years in quality, engineering, or manufacturing within medtech, pharma, biotech, or combination products; working knowledge of 21 CFR Part 820 & Part 4, ISO 13485, ISO 14971, EU MDR; familiarity with Design Controls, risk management, V&V, design transfer; effective communication, organization, analytical skills; ability to work independently. Preferred: experience with combination products or drug delivery devices. HighValue: combination products, medical devices, regulatory compliance (FDA, EU MDR), Design Controls, risk management, quality systems, vendor oversight. WorkSetup: location unspecified; no travel mentioned.