Job Description
Position Title : Supplier Quality Engineer Responsibilities: Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements. Lead and support internal and external audits, including FDA, Notified Body, and customer or supplier audits. Maintain and improve Quality Management System (QMS) procedures and documentation. Lead investigations for nonconformances (NCRs), complaints, and CAPA activities using structured problem‑solving tools (e.g., 5 Why, Fishbone, DMAIC). Ensure timely closure and effectiveness verification of supplier corrective and preventive actions. Support risk assessments for changes, process changes, and nonconformities. Review and approve supplier IQ/OQ/PQ validation protocols and reports. Ensure statistical techniques (e.g., Gage R&R, SPC, sampling plans) are correctly applied by supplier. Collaborate with cross‑functional teams (Engineering, Manufacturing, RA, Supply Chain) to support timely implementation of activities related to...