Supporting companywide continuous quality improvement towards absolute zero-defect culture.
Ensures Quality Policy & Quality Objectives and Management Review Processes are in place;
Quality System Management: Implements the performance measurements necessary to effectively evaluate organizational performance and trends in product quality, services, customer satisfaction and the cost of poor quality;
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Perform QMS audit to vendors within scope of medical device, drug product, cosmetic product and lab, write audit report, and follow-up supplier CAPA.
Work as project leader in Vendor FDA project, supervise vendor to adequately establish and maintain QMS based on 21CFR820 or 21CFR210&211, and support vendor for FDA audit, act as consultant to help vendor establish a better QMS with professional suggestions.
Monitor vendors’ quality management system with proper visiting in key vendor FDA projects, identify their QMS problems under regular review.
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Set up, start, operate, stop, and adjust plastic machining equipment according to approved work instructions, engineering drawings, and production requirements.
Monitor machine performance and make routine adjustments to maintain product quality and production efficiency.
Load raw materials and unload finished parts while ensuring proper handling and traceability.
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Set up, start, operate, stop, and adjust plastic machining equipment according to approved work instructions, engineering drawings, and production requirements.
Monitor machine performance and make routine adjustments to maintain product quality and production efficiency.
Load raw materials and unload finished parts while ensuring proper handling and traceability.
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Perform special process activities such as masking, unmasking, spraying, touch-up, packing, and documentation according to work instructions and customer requirements.
Perform part jigging/un-jigging, bonding, masking, paint mixing, packing, housekeeping, and other production activities.
Operate masking and painting processes according to the Special Process Operation Instruction (SPOI).
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Risk Management: Support maintenance of the risk register, coordinate risk reporting submissions, and assist in preparing materials for Risk Review meetings and committee reporting.
Accreditation & Audits: Coordinate accreditation activities, track compliance with regulatory standards, and monitor progress of corrective action plans.
Quality Improvement: Support patient safety and quality initiatives, including reporting, awareness activities, and monitoring of improvement metrics.
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Act as SGS Malaysia’s technical specialist for Gas Chromatography instrumentation and related analytical testing in food, consumer products and chemical laboratory services.
Train internal laboratory teams and build capability in GC operation, sample preparation, method setup, calibration, troubleshooting, result interpretation and technical reporting.
Establish, review and improve standards, procedures, test methods, work instructions, calibration practices, quality control checks and laboratory methodologies.
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Provide daily support for Oracle production, enhancement projects and lean initiatives related to Fusion Cloud and Oracle EBS.
Facilitate business and systems analysis discussions and translate findings into clearly defined Business Requirements Document and Functional Design Document.
Work with the development team in reviewing the Technical Design, validating to ensure the development delivers to the design.
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