Quality Engineer

Job Description: Activities and relevant KPI Targets: The following processes are key to QE performance within Nextern and between Nextern and our key customer collaborators. This role must be proficient at achieving outcomes on-time, with high quality documentation content, and cross-functional team awareness/support (internal & external).Create required documentation that relevant to product specifications and requirements (Process flow, control plan, inspection criteria…)Manage inspection report follow AQL for each shipment and/or production lot. Review device history record and approve the product dispositionProcess Qualification & ValidationEquipment (Functional Test, Assembly Fixtures, Manufacturing Aids, ETC…) Selection & QualificationProcess Control & Yield/Trend MonitoringCustomer complaint support regarding the Failure Analysis of Returned Products (Out of Box & Fielded), Return Material Authorization (Customers to Nextern), Return Material Authorization (Intra Nextern). Servicing & Refurbishment of Fielded ProductsNon-Conforming Material Processing (Manufacturing, Supplier, & Engineering Change Causes)Audit, CAPA & SCAR Processes supportOther responsibilities assigned by the superior. The following processes are key to QE performance follow the superior appointment:Incoming control activities, including but not limited toPrepare Incoming Inspection Criteria. Ensure that all related inspection and testing activities with regard to the established standards.Control inspection materials in both ERP system and physical. Maintain record of inspection, testing, equipment calibration, maintenance, ETC. per procedures. Scan & archive records in the control system.Process control activities, including but not limited toPerform the Equip/Process Qualifications. Control of Equipment Calibration & Preventive Maintenance.Follow up in-process control activities, review DHR and perform product dispositionSupplier Quality management activities, including but not limited toInitialize PPAP (Production Part Approval Process) to supplier, gather and maintain all required documentation.Maintains PPAP master samplesTravel to supplier locations to conduct audits and inspectionsImprovement activitiesInitiate timely CAPA, SCAR, Non-Conforming Material Processing and follow upMaterial Issue Investigation Lead, NC product disposition Lead, Traceability LeadCustomer complaint investigation supportBuild excellent quality reports.

Technical Expertise: The Nextern’s product types will require technical expertise to contain issues, determine root cause of issues, drive corrective actions internal to Nextern and collaboratively with customer collaborators, and collaborate with the supplier management organization on effective corrective/preventive actions to be implemented by the supplier, as needed. The experience of following technical knowledges are the strong advantages of the candidatePrinted Circuit Board AssembliesPneumatic Pumps & ValvesCables & wired interconnect assembliesMolded Plastic Parts (including pad/laser print suppliers)Gluing, Mating, and Fastening Processes for EnclosuresDisplaysPower SuppliesMechanical fastener & chassis componentsElectromechanical connectors & fasteners Qualification Bachelor’s degree or higher of technical university (University of Technology is preferred)Minimum 4 years’ experience in process quality management. Experience in medical device is preferredISO9001:2015 certification is mandatory (ISO13485 certification is preferred)Experience in Solving problems (follow 8D).Experience in statistical and risk management (FMEA).Experience in process qualification.Experience in excel (especially VBA), word, excel and PowerPoint.Language: must be highly fluent in English (written & verbal).Knowledge about improving concepts (Kaizen, 6 sigma, lean manufacturing...) is preferred. Physical Demands and Work Environment:Able to work overtime and accept meeting at night several times weekly.Able to work under high pressure.Able to work in cleanroom class 8