Packaging/Medical Device Quality Specialist

As part of the Quality for Combination Products and Medical Devices (CP/MD QA) department, the Combination Product and Medical Device and Packaging QA Associate represents Quality in global teams involved in the design, development, manufacture, and regulatory approval of CSL combination products. These products include medical device constituent parts developed to enable convenience, monitoring, compliance, and effective outcomes for patients.

This role ensures new product development activities for CSL combination product projects follow a 21 CFR Part 4-compliant quality system. The role serves as a subject matter expert on medical device and combination product requirements in accordance with FDA and EU MDR regulations, ISO standards, and industry best practices, with an emphasis on the Design Controls process. The position supports quality-related activities throughout the product lifecycle from concept through industrialization and post-market support, collaborating with...