Senior Supplier Quality Engineer

Repligen seeks a Senior Supplier Quality Engineer to manage supplier qualification, audits, and performance in a regulated manufacturing environment. The role involves evaluating supplier capabilities, investigating quality issues, and collaborating across functions to ensure compliance and continuous improvement.

Responsibilities

• Conduct technical evaluations and qualification activities for new and existing suppliers
• Plan and execute supplier audits, document findings, and track corrective actions
• Lead nonconformance investigations and supplier corrective action requests with root cause analysis
• Evaluate supplier change notifications and assess quality and regulatory impacts
• Monitor supplier performance through scorecards, trends, and key performance indicators

Requirements

• Bachelor's degree in Engineering, Quality, Life Sciences, or related technical field
• 7+ years supplier quality, quality engineering, or manufacturing quality experience
• Proficiency with supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis
• Knowledge of GMP, FDA requirements, and quality management systems
• Ability to evaluate manufacturing processes and supplier quality systems
• Strong problem-solving, analytical, and cross-functional collaboration skills
• Willingness to travel to supplier facilities as needed