Supplier Quality Engineer

Supplier Quality EngineerThe Supplier Quality Engineer is responsible for leading supplier quality activities during design transfer and process/product validation. This role ensures supplier compliance to applicable requirements, including 21CFR, ISO 13485, and drives supplier development and performance management processes. The SQE serves as a key technical and quality liaison between the DEKA design team and manufacturing partners with primary responsibility for ensuring suppliers are capable of consistently meeting quality, regulatory, and performance expectations. This role will heavily support process and tool validation support, while also managing sustaining supplier quality performance for production materials and services.How you will make an impact as a Supplier Quality Engineer:Review and approve supplier documentation including certifications, validations, and quality recordsEnsure supplier readiness for production launch, including quality systems, and process controlsParticipate in design transfer and process/tool validation activities such as IQ/OQ/PQ, MSA and Statistical analysisSustaining Supplier Quality ManagementSupplier development and continuous improvement to ensure effective design transferMonitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)Lead/Support 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 issuesSupplier Quality System & ComplianceEnsure supplier compliance with applicable regulatory and quality system requirements including ISO 13485Support external and internal audits involving supplier quality systemsDrive adherence to change notification and supplier control requirementsCross-Functional CollaborationPartner with Contract Manufacturing, Procurement, and EngineeringSupport material nonconformance investigations and disposition decisionsProvide supplier risk input to project teams and change control processesSupport supply continuity and risk mitigation strategiesWriting Test Methods to support ValidationSkills 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 medical device manufacturing and global supply chainsAbility to interpret mechanical drawingsFamiliarity with statistical tools (Minitab), risk analysis (FMEA), and CAPA systemsExperience in process and tool validationStrong 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 (Supplier Quality Professional, Green Belt, CQE, CQA, or similar) are a plus.