Supplier Quality Engineer

Key Responsibilities & Required Qualifications:

• Bachelor’s degree in Engineering, Quality, or a related technical field.
• 7+ years of experience in Supplier Quality Engineering, Manufacturing Engineering, or Quality Assurance.
• Experience with supplier quality management systems, process audits, and ISO 9001.
• Strong knowledge of root cause analysis, CAPA, risk assessment, and quality improvement methodologies.
• Familiarity with FDA, GMP, eQMS systems, and digital audit tools.
• Excellent communication, problem-solving, and stakeholder management skills.
• Willingness to travel for supplier audits and evaluations.
• Conduct supplier audits, qualifications, and risk assessments to ensure compliance with ISO 9001, FDA, GMP, and internal quality standards.
• Manage Supplier Corrective Action Requests (SCARs), Non-Conformance Material Reports (NCMRs), and Supplier Change Notifications (SCNs).
• Perform root cause analysis and drive effective corrective and preventive actions (CAPA).