Supplier Quality Engineer

Position Title : Supplier Quality Engineer

Responsibilities
Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirementLead and support internal and external audits, including FDA, Notified Body, and customer or supplier audits.Maintain and improve Quality Management System (QMS) procedures and documentationLead 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 actionSupport risk assessments for changes, process changes, and nonconformitiesReview and approve supplier IQ/OQ/PQ validation protocols and reportsEnsure statistical techniques (e.g., Gage R&R, SPC, sampling plans) are correctly applied by supplierCollaborate with cross‑functional teams (Engineering, Manufacturing, RA, Supply Chain) to support timely implementation of activities related to validation or supplier quality concernsDevelop and track quality metrics (e.g., scorecard, supplier NCs, MRB)Supervise suppliers’ quality performance, push suppliers to improve their performanceManage and improve IQC & SQE document.
Qualification:
Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other global regulatory standardsExperience with risk management per ISO 14971.Proficiency in process validation (IQ/OQ/PQ), test method validation, and equipment qualification.Knowledge of statistical analysis and tools: SPC, Minitab, Gage R&R, sampling plans (ANSI/ASQ Z1.4).Experience working with QMS systems, documentation control, and audit readiness.Understanding of manufacturing processes, process controls, and defect prevention.Familiarity with design control and DHF/DMR requirements.