Supplier Quality Engineer

We have an position for a Supplier Quality Engineer with a global life sciences manufacturer specializing in advanced bioprocessing technologies that support leading biotech and pharmaceutical organizations. The Supplier Quality Engineer will play a key role within a growing Supplier Quality organization, ensuring the quality, compliance, and performance of a global supplier base. This role blends engineering expertise, auditing capability, and cross-functional collaboration to maintain high standards across the supply chain. You'll join a tight-knit team of three quality professionals and report directly to the Senior Manager of Supplier Quality, contributing to meaningful, cutting-edge work in a dynamic environment. Key Responsibilities Supplier Development Identify capability gaps, drive continuous improvement, and partner with Sourcing on strategic supplier performance. Supplier Change Notifications (SCNs) Evaluate, document, and analyze supplier changes; coordinate cross-functional risk reviews. Supplier Qualifications Conduct technical evaluations and process reviews for new and existing suppliers. Supplier Corrective Action Requests (SCARs) Initiate, manage, and verify corrective actions; standardize closure timelines and root-cause quality. Non-Conformance Material Reports (NCMRs) Lead NCMR investigations, trend analysis, and escalation for high-risk issues. Supplier Performance & Scorecards Maintain scorecards and collaborate with suppliers on improvement plans. Approved Supplier List (ASL) Maintenance Ensure accurate supplier status and requalification. Supplier Audits Plan and execute on-site and remote audits; deliver detailed audit reports and risk assessments. Risk Assessments Evaluate supplier risk and develop mitigation strategies. Continuous Improvement Use engineering and statistical tools to optimize supplier processes. Product & Process Validation Support first article inspections, capability studies, and technical evaluations. Regulatory Compliance Ensure adherence to FDA, GMP, and other applicable standards. Cross-Functional Collaboration Act as a liaison between Quality, Procurement, Engineering, and Regulatory teams. Required Qualifications Bachelor's degree in Engineering , Quality , or a related technical field. 7+ years in supplier quality , manufacturing engineering , or quality assurance . Experience with ISO 9001 , supplier QMS audits, and process auditing. Strong root cause analysis and corrective action skills. Proficiency with risk assessments , quality audits , and eQMS/digital audit tools. Familiarity with FDA , GMP , and other regulatory standards. Excellent communication, negotiation, and interpersonal skills. Willingness to travel for supplier audits and evaluations. (Hybrid - Waltham, MA) Salary-$110-$130k DOE KPG123