Packaging/Medical Device Quality Engineer

Role: Medical Device and Packaging QA Associate within the Quality for Combination Products and Medical Devices department, responsible for ensuring design, development, manufacturing, and regulatory approval of CSL combination products meet global quality standards. Responsibilities: serve as QA subject matter expert on regulatory requirements (FDA, EU MDR, ISO), support design control processes, oversee vendor quality compliance through audits and performance reviews, maintain and improve quality systems aligned with 21 CFR Part 4 and MDR, and conduct root cause analyses. Collaborate with cross-functional teams across global sites throughout the product lifecycle, from concept to post-market support. Requirements: Bachelor's in mechanical, biomedical, or related sciences; minimum 5 years’ experience in medical device or combination product quality, manufacturing, or packaging; strong knowledge of 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and industry standards; experience with design controls, risk management, V&V, and product development lifecycle. Preferred: experience in drug-delivery combination products, embedded software, mobile health solutions. Competencies: effective communication, problem-solving, planning, assertiveness, and collaboration skills. High-value specifics: focus on combination products with embedded software and connected health solutions, in a regulated environment. Work setup: not specified; travel requirements not detailed.