Job Description
Overview
Job Summary
Bring your expertise in compliance, design controls, assay design, and system integration principles to the forefront of quality, science, and impact. As a Staff Quality Engineer within Werfen's Autoimmunity business, you will play a pivotal role in ensuring the safety, efficacy, and regulatory excellence of innovative IVD and medical device products. Partnering closely with R&D, Manufacturing, and cross‑functional leaders, you will help implement quality strategy across the full product lifecycle—from design and development through post‑market surveillance—while driving continuous improvement and influencing critical decisions. This is a highly visible individual‑contributor role for a seasoned quality professional who thrives on technical challenge, mentorship, and shaping robust, audit‑ready systems in a fast‑paced, evolving environment.
Responsibilities
Key Accountabilities