Job Description:This role is responsible for end-to-end supplier quality management for medical device products, with a strong emphasis on process verification and validation, supplier audits, and change management. The Supplier Quality Engineer ensures suppliers consistently meet regulatory, quality, and manufacturing requirements, supporting robust product realization and lifecycle management. The role collaborates closely with Quality Assurance, Engineering, Manufacturing, Regulatory Affairs, and Sourcing teams, as well as external suppliers, to ensure compliant, efficient, and scalable supplier operations.Qualification:Bachelor's degree in mechanical engineering or a related technical discipline5+ years of experience in Supplier Quality Engineering within the medical device industryProven experience in supplier process verification and validationStrong knowledge of ISO 13485:2016 and medical device regulatory requirementsExcellent communication, analytical, and problem-solving skillsDemonstrated ability to learn, adapt, and drive continuous improvementIn-depth understanding of industry standards, supplier quality practices, and company quality systemsJob Responsibilities:Manages assigned suppliers and act as the primary quality interface between suppliers and internal teams, serving as the central point of contact.Monitor supplier performance against defined quality metrics and drive improvement actions.Support supplier selection, qualification, and development activities.Collaborate with Engineering, Manufacturing, Sourcing, and Quality teams during new product and supplier development.Review, approve, and support Process Verification & Validation activities, including IQ, OQ, and PQ documentation.Supports/Drives the suppliers to build their master process validation plan and monitor the execution progress.Drive the efficient processing of supplier change requests by standardizing initiation, conducting quality impact reviews, and communicating progress effectively.Review and manage supplier change requests using Windchill Change Management, including quality impact assessment.Effectively review product risk management activities (including Risk Analysis, Risk Management Report)Proactively audit supplier QMS, Process & Product focusing on production, process, and quality control.Works directly with suppliers to address quality issues, ensure timely corrective actions (CAPA/SCAR), and drive quality improvements.Facilitate the transfer of knowledge from development to regular production process at the start of supplier mass production.Completes the other tasks assigned by Supervisor / Manager.SkillsProficient in MS Office (including Word, Excel, Power Point etc).Strong analytical, problem-solving, and communication skillsKnowledge of ISO 9001, ISO 13485, ISO 14001, ISO 45001, FDA, EU MDR / IVDR, MDSAP and regional medical device regulatory requirements.Complete understanding of quality assurance, auditing principles and concepts, total quality tools, continual improvement approaches, industry practices, and standards.CAPA / 8D Methodology, Root Cause AnalysisProcess Verification & Validation (IQ, OQ, PQ)Windchill PLM & Change ManagementSupplier Audits (QMS, Process, Product)Quality Tools: APQP, PPAP, PFMEA, MSA, SPCSix Sigma Methodology