Assist in implementing, maintaining, and continuously improving quality control procedures, standards, and documentation.
Prepare, review, and update inspection records, including raw material, packaging material, and finished product inspection forms, labels, and packaging documentation.
Perform daily QC administrative activities, including issuing QC Pass stickers for approved raw materials, packaging materials, and finished products.
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Quality engineers define quality standards for the creation of products or services. They check to make sure the products and services are in compliance with the quality standards and they coordinate quality improvements.
Basic computer knowledge like Microsoft Excel / Word
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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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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Ability to investigate production issues, handle customer complaints, conduct root cause analysis, identify trends, and implement Corrective and Preventive Actions.
Proven experience in supervising team members and managing daily QA operations.
Able to work effectively with cross-functional teams, particularly production team.
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