Senior Supplier Quality Engineer

The Senior Supplier Quality Engineer (Sr. SQE) is responsible for leading supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations. This role ensures supplier compliance to applicable requirements, including 21CFR, ISO 13485, and drives robust supplier qualification, development, and performance management processes.The Sr. SQE serves as a key technical and quality liaison between DEKA, manufacturing partner and its supplier base, with primary responsibility for ensuring suppliers are capable of consistently meeting quality, regulatory, and performance expectations. This role will heavily support supplier qualification activities for NPI programs, including process validation support, and onboarding of new suppliers, while also managing sustaining supplier quality performance for production materials and services.How you will make an impact as a Senior Supplier Quality Engineer:Lead supplier qualification activities for New Product Introduction (NPI) projectsPerform risk-based supplier assessments aligned with product and process criticalitySupport supplier selection decisions in collaboration with Design Authority (customer), Engineering, Procurement, and Quality AssuranceConduct supplier audits (remote and onsite) for new and existing suppliersReview and approve supplier documentation including certifications, validations, and quality recordsEnsure supplier readiness for production launch, including capacity, quality systems, and process controlsParticipate in design transfer and process validation activities where supplier input is requiredSustaining Supplier Quality ManagementOwn supplier quality oversight for assigned NPI projects and production suppliersMonitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)Lead supplier corrective action activities (SCAR/CAPA) and ensure timely closureConduct supplier performance reviews and drive continuous improvement initiativesSupport containment, root cause analysis, and resolution of supplier-related quality issuesPerform risk-based supplier re-evaluations and periodic assessmentsSupplier Quality System & ComplianceEnsure supplier compliance with applicable regulatory and quality system requirements including ISO 13485Maintain and improve Approved Supplier List (ASL) classification and risk-based controlsSupport external and internal audits involving supplier quality systemsEnsure supplier quality agreements are established and maintainedDrive adherence to change notification and supplier control requirementsCross-Functional CollaborationPartner with Design Authority (customer), Procurement, Manufacturing and EngineeringSupport material nonconformance investigations and disposition decisionsProvide supplier risk input to project teams and change control processesSupport supply continuity and risk mitigation strategiesSkills you will need to be successful in this role:Bachelor's degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.3-5 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industryStrong knowledge of ISO 13485 and medical device regulatory requirementsExperience with supplier audits, qualification, and risk-based supplier managementExperience supporting NPI or design transfer activities strongly preferredStrong understanding of manufacturing processes, validation, and quality systems.Skills & CompetenciesExperience with contract manufacturing and global supply chainsAbility interpret mechanical drawings (CAD files)Familiarity with statistical tools, risk analysis (FMEA), and CAPA systemsExperience in lean manufacturing or continuous improvement environmentsStrong technical judgment and problem-solving skillsAbility to lead supplier interactions and drive accountabilityExcellent communication and cross-functional collaboration skillsStrong root cause analysis and data-driven decision-making capabilityAbility to manage multiple priorities in a fast-paced NPI and production environmentHigh attention to detail and regulatory compliance mindsetWillingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travelPreferred CertificationsISO 13485 Internal Auditor certification preferred.ASQ certifications (CQE, CQA, or similar) are a plus.#J-18808-Ljbffr