Supplier Quality Engineer

Role: Supplier Quality Engineer responsible for ensuring the quality, compliance, and performance of Repligen’s global supplier network. Primary objectives include supplier qualification, audit management, handling quality issues, change management, and performance monitoring. Responsibilities involve conducting technical evaluations, planning and executing supplier audits, leading root cause investigations, evaluating change notifications, and supporting supplier development and risk mitigation. Collaboration spans Quality, Sourcing, Engineering, Operations, and Regulatory teams. Qualifications: Bachelor's degree in Engineering, Quality, Life Sciences, or related field; 2+ years in Supplier Quality or related roles; experience with supplier audits, nonconformance investigations, CAPA/SCAR, and regulatory requirements including GMP and FDA. Skills include technical process evaluation, problem-solving, cross-functional communication, and travel flexibility. High-Value: focus on bioprocessing supply chain, ensuring supplier qualification and compliance; role involves vendor assessments, supplier audits, CAPA, and risk management. Work setup includes roles based in Waltham or Hopkinton, MA, with travel as needed.