Supplier Quality Engineer

Job Title: Supplier Quality Engineer / SpecialistLocation: MAExperience: 5+ YearsEmployment Type: [Contract]Job SummaryWe are seeking an experienced Supplier Quality Engineer to ensure the quality and compliance of externally sourced materials and components. The ideal candidate will work closely with suppliers and internal cross-functional teams to drive quality improvements, manage supplier performance, and ensure adherence to regulatory and quality standards.Key ResponsibilitiesManage supplier qualification, evaluation, and approval processesConduct supplier audits (on-site/remote) to ensure compliance with quality standardsMonitor supplier performance using KPIs and drive continuous improvement initiativesLead root cause analysis (RCA) and corrective/preventive actions (CAPA) related to supplier issuesReview and approve supplier documentation including specifications, test methods, and quality agreementsCollaborate with Procurement, Manufacturing, R&D, and Quality teamsSupport incoming material quality issues and supplier-related deviations/NCRsEnsure compliance with FDA, ISO standards (ISO 13485/9001), and GMP/GxP regulationsParticipate in change control processes involving suppliersSupport regulatory inspections and internal/external auditsRequired QualificationsBachelor’s degree in Engineering, Life Sciences, or related field5+ years of experience in Supplier Quality / Quality AssuranceExperience in regulated industries (Medical Devices / Pharma / Biotech)Strong knowledge of FDA regulations, ISO standards, and GMP/GxPHands-on experience with supplier audits and qualification processesExperience with CAPA, deviation management, and change controlExcellent problem-solving and analytical skillsPreferred QualificationsASQ Certification (CQE, CQA) or Six Sigma (Green/Black Belt)Experience with quality systems (TrackWise, SAP, Veeva, EtQ, etc.)Strong knowledge of risk management (FMEA, HACCP)Experience working with global suppliersKey SkillsSupplier Quality ManagementRoot Cause Analysis (RCA)CAPA & Deviation ManagementSupplier Audits & QualificationRegulatory Compliance (FDA, ISO, GMP)Risk Management (FMEA)