Partner with cross-functional teams to identify product risks, investigate potential failure modes, and implement effective risk control measures.
Ensure compliance with ISO 13485, FDA regulations, customer requirements, and applicable quality standards.
Develop, review, and maintain quality procedures, SOPs, and documentation to support product development and Quality Management System (QMS) requirements.
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Ensure products comply with customer specifications, semiconductor industry requirements, and applicable quality standards.
Monitor and analyze quality KPIs, including defect rate, customer complaints, yield, First Pass Yield (FPY), scrap rate, and Cost of Poor Quality (COPQ).
Lead investigations into customer complaints, internal quality issues, and supplier quality concerns, and implement corrective and preventive actions (CAPA).
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Responsible for the construction material such as specification and quality of material, stockpile and protection and other matter related to construction materials at the project site.
Responsible for the compilation of documentation such as quality record, checklist, report, plan and any other documents which related to site QAQC activities.
Responsible for implementing of internal Non-Conformance Report (NCR) on nonconformities throughout the project site.
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Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects.
Perform a spot-check of activities for the oversight areas to ensure compliance with quality standards.
Ensure adherence to frequency of oversight mandated in the Quality oversight schedule.
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Computer literate (Word, Excel, Oracle database, Electronic Documentation System) to create spreadsheets, e-mail, memos, graphic, etc. and technical writing skills (create and edit complex procedures)
Possess effective time management and organizational skills; able to balance multiple priorities and having the ability to interact and communicate effectively with both internal and external stakeholders
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Communicate clearly audit results and recommendations to the management/Board as well as ensure timely issuance of report
Validate remediation actions and perform post-audit verification for audit observation closure to ensure sustainable fixes/remediation of root-cause
Develop/maintain quality and timely audit documentation i.e. audit programmes and work papers that support audit conclusions and in accordance with the internal audit methodology
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Assist in investigating feasible optimization suggestions for existing quality and efficiency pain points of the engineering and algorithm teams, and drive the implementation of solutions to improve delivery quality and efficiency.
Keep track of cutting-edge technologies related to large models and AIGC, explore new quality and efficiency solutions for quality assurance scenarios, and iterate continuously in practice.
Final year or graduated with a background in Software Development, Computer Science, Computer Engineering, or a related technical discipline
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