Senior Supplier Quality Engineer

Job description

Are you passionate about driving supplier excellence and ensuring compliance in a fast-paced, global environment? Hologic is seeking a Senior Supplier Quality Engineer to support our Global Supplier Quality organization, ensuring that components, materials, and services from suppliers consistently meet stringent quality and regulatory requirements. In this role, you’ll assess and qualify suppliers, oversee their manufacturing and quality practices, resolve supplier nonconformances, and lead data‑driven improvements using tools like PPAP, SPC, GR&R, and CAPA. You’ll partner closely with R&D, Design Assurance, Post‑Market, Manufacturing, and global suppliers to protect product quality, reliability, and patient safety. If you enjoy technical problem solving, supplier collaboration, and being a key gatekeeper for incoming quality in a regulated environment, this role is for you. Knowledge: - Strong working knowledge of medical device and IVD regulations, including: - cGMP - 21 CFR 820 (QSR) - ISO 13485, ISO 14971, ISO 9001 - MDR/IVDR and other global regulations (e.g., FDA, Canada, Brazil, Japan). - Deep familiarity with supplier quality management practices, including qualification, p...