Supplier Quality Engineer

Role: Supplier Quality Engineer Location: Massachusetts | Onsite Job Summary We are seeking an experienced Supplier Quality Engineer with a strong background in the medical device or regulated life sciences industry. The ideal candidate will have hands-on experience managing supplier quality activities, supplier qualification, audits, SCARs, CAPA, non conformances, and quality investigations within a regulated manufacturing environment. This role will work closely with Suppliers, Quality, Engineering, Manufacturing, Procurement, and other cross-functional teams to ensure supplier compliance, resolve quality issues, and drive continuous improvement. Key Responsibilities Manage supplier quality activities for medical device components, materials, and services. Qualify, evaluate, and monitor new and existing suppliers. Conduct and support supplier audits, assessments, and performance reviews. Manage Supplier Corrective Action Requests (SCARs) and drive timely resolution of supplier quality issues. Review supplier specifications, quality agreements, documentation, and change notifications. Support root cause investigations, CAPA, nonconformances, and corrective actions. Monitor supplier performance related to quality, delivery, compliance, and continuous improvement. Partner with Engineering, Manufacturing, Quality, Procurement, and suppliers to resolve quality issues. Support incoming inspection and supplier-related nonconformance investigations. Ensure supplier activities comply with FDA, ISO 13485, and applicable medical device quality system requirements. Support supplier development, process improvements, and quality improvement initiatives. Maintain accurate supplier quality records and documentation in accordance with company procedures. Required Qualifications Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical field. 3+ years of Supplier Quality Engineering experience, preferably within the medical device industry. Strong experience with supplier quality, SCAR, CAPA, nonconformance, root cause analysis, and supplier audits. Working knowledge of ISO 13485 and FDA Quality System requirements. Experience with quality tools such as 8D, FMEA, SPC, MSA, and Root Cause Analysis. Ability to work effectively with suppliers and cross-functional teams. Strong analytical, documentation, problem-solving, and communication skills. Must have Qualifications Experience with medical device, mechanical, or electromechanical components. Experience in supplier qualification and supplier development. Experience supporting supplier, design, and process changes. Knowledge of FDA 21 CFR Part 820 / QMSR requirements. Experience with ERP/QMS systems and supplier performance metrics.

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