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 with cross‑functional teams (Engineering, Manufacturing, RA, Supply Chain) to support timely implementation of activities related to validation or supplier quality concerns.
• Develop and track quality metrics (e.g., scorecard, supplier NCs, MRB)
• Supervise suppliers’ quality performance, push suppliers to improve their performance.
• Manage and improve IQC & SQE document.

Qualification:

• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other global regulatory standards.
• Experience 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.