Supplier Quality Engineer

Job Description:

• Lead the evaluation and qualification of suppliers for raw materials, components, and services used in drug product manufacturing
• Plan, conduct, and document supplier audits to ensure compliance with cGMP, ISO 13485, and internal quality standards
• Partner with sourcing and procurement to develop and maintain a robust approved supplier list
• Investigate supplier-related quality issues, conduct root cause analysis, and lead resolution through CAPA and SCAR processes
• Analyze supplier performance data to identify trends, mitigate risk, and support continuous improvement initiatives
• Review supplier documentation including change notifications, quality agreements, and certificates of analysis
• Represent Supplier Quality in cross-functional meetings and contribute to regulatory and customer audit responses

Qualifications:

• Bachelor’s degree in Engineering, Chemistry, Biology, or related technical field
• Minimum 3 years of experience in supplier quality or quality engineering in the pharmaceutical, biotech, or medical device industry
• Strong working knowledge of cGMP regulations, FDA, ISO 13485, and ICH Q10
• Experience with supplier audits, validation support, and external communication
• Proficiency in quality tools such as FMEA, Root Cause Analysis, 8D, and Risk Management
• Excellent organizational and interpersonal communication skills