Supplier Quality Engineer

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 ...