Staff NPI Process Quality Engineer

Description

Summary:

We are seeking a highly motivated and detail-oriented New Product Development (NPD) Quality Engineer to join our team. This role is embedded within a cross-functional core team and plays a critical part in both ensuring compliance and driving efficiency in the design and development lifecycle. The primary focus of this position is to streamline and optimize design control processes to support the efficient and compliant development of In Vitro Diagnostic (IVD) products, including Research Use Only (RUO), IVD-CE marked, and clinical diagnostic products intended for global markets.

The successful candidate will bring hands-on experience as a Quality Engineer supporting product development, along with a demonstrated ability to improve and scale quality processes. The role spans reagent systems, complex instrumentation, and software/informatics platforms across both New Product Introduction (NPI) and sustaining activities. Thi...