Senior Supplier Quality Engineer

Job Description:

• Lead and manage supplier quality programs for raw materials, components, and outsourced services
• Conduct risk assessments and develop strategies for supplier onboarding and lifecycle management
• Serve as primary point of contact for key suppliers regarding quality issues, audit schedules, and technical reviews
• Oversee change control processes related to supplier-initiated changes and evaluate impact to product quality
• Work cross-functionally with QA, Operations, and Regulatory Affairs to meet compliance standards
• Maintain robust metrics and KPIs to monitor supplier performance and drive improvements
• Participate in internal and external audits and provide documentation support

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related discipline
• 5+ years of supplier quality experience in biotech, pharma, or medical device manufacturing
• Strong knowledge of cGMP, ISO 13485, and supplier management systems
• Demonstrated ability to lead audits and implement supplier improvement initiatives
• Excellent communication, problem-solving, and analytical skills