The Incoming / Supplier Quality Engineer is responsible for ensuring consistent quality of materials, components, and purchased products through the establishment and enforcement of quality standards. This includes inspecting and releasing incoming materials, monitoring suppliers’ daily quality performance, preparing quality reports, and implementing corrective action programs. This role is essential to ensure that the processes defined for product manufacturing incorporate all required quality standards from the receiving stage. The position works closely with the Purchasing, Engineering, and Production departments, providing technical support and assisting in supplier selection and evaluation from a quality perspective when required. The position ensures compliance with applicable requirements of the Quality and Environmental Management System , including ISO 9001, ISO 13485, FDA QMSR (21 CFR 820) , and ISO 14001 . 1. Material Inspection and Release Verify raw materials, components, and purchased products against engineering drawings, specifications, and applicable standards. Perform visual, dimensional, and functional inspections. Authorize the release or rejection of received materials. Identify, segregate, and control nonconforming material. 2. Safety and Certification Compliance Coordinate compliance with safety requirements during incoming material inspections. Review and verify requirements from certification bodies such as UL, TÜV, CQC , and others as applicable. 3. Nonconformance and CAPA Management Document material rejections and Nonconformance Reports (NCRs). Perform root cause analysis of recurring defects using tools such as 5 Whys, Ishikawa (Fishbone), Pareto , etc. Follow up on corrective and preventive actions (CAPA). Coordinate rework, returns, or use-as-is concessions with cross-functional teams. 4. Documentation and Regulatory Control Ensure compliance with applicable quality and regulatory standards (ISO 9001, ISO 13485, 21 CFR 820, ISO 14001). Education Bachelor’s degree in Engineering required. Mechanical or Electronic Engineering is preferred. Equivalent combination of education and experience is acceptable (minimum 5 years of relevant professional experience ). Work Experience Minimum 3 years of experience as a Quality Engineer , preferably in the medical device or electronics industry . Fundamental knowledge of: Electronics Plastics Assembly and manufacturing processes Experience with battery components is a plus. Proven experience in: FMEA development 5S methodologies Gage R&R CPK studies Implementation of Statistical Process Control (SPC) Language Skills Advanced English level required . Must be able to read, write, and present technical information fluently. Capable of participating in project presentations and negotiation processes . Computer & Technical Skills Proficient in Microsoft Office applications (Excel, Word, PowerPoint). Experience using Minitab for statistical analysis. Ability to use specialized inspection and test equipment . Core Competencies Strong communication skills with the ability to interact effectively at all organizational levels. Demonstrated capability in technical writing and documentation . Analytical mindset with strong problem-solving skills. Ability to work cross-functionally with Engineering, Purchasing, and Production teams. Additional Requirements / Preferred Qualifications ASQC and/or Six Sigma certification is a plus. Experience working with FDA regulations , ISO 13485 , and/or ISO 9001 standards is highly desirable. Willingness to actively participate on the manufacturing floor. Availability for occasional travel to customers, suppliers, and other company locations as required. #J-18808-Ljbffr