QA Engineer [3년~10년] > Order

Primary Responsibilities
- Analyzing supplier, operation and customer data, complaints and defective products to determine trends and recommends corrective / preventative actions
- Interfacing with suppliers, operations, customer and regulatory representatives concerning quality problems, ensures effective corrective action is implemented and develops prevention based quality improvement programs

• Ensure the supplier operations are in compliance with local regulatory/legal and Amway quality requirements
• Lead communications with suppliers to enhance mutual understandings and to get aligned well
• Develop and implement CAPAs with suppliers against the quality observations and potential risks found

- Ensuring that products, materials and services comply with established specifications and technical requirements through application of quality tools and principles
- Designing the appropriate models and tools for ensuring effective communication, delivery and training of quality programs, processes and systems (including cGMP, ISO, etc.)
- Review of test-related chemical analysis results for compliance with government regulations.
- Ensure to minimize business interruption and loss due to quality issues by swift communication, escalation, decisions and actions
- Support quality audits of suppliers through follow up on CAPA actions and support supplier development by helping to reinforce the supplier's quality system
- Representing customer to resolve product design and quality issues
- Closely work with cross functional team in region and global to fulfill their expectation and deliver value to business

Requirements
-  Quality assurance / quality control principles and tools
-  Quality assurance fundamentals in both regulated and non-regulated environments
-  Good Manufacturing Practices (GMPs)
-  Broad range of manufacturing operations with experience assessing quality risks in a variety of manufacturing settings
-  Effectively communicating both verbally and written at all levels (horizontally and vertically / internally and externally)
-  Investigating process deviations to identify root cause and effective preventive measures
-  Organized and detail-oriented with the ability to independently recognize and balance changing priorities to include interruptions, deadline revisions and managing of critical shipments / production orders
-  Efficiently and professionally completing tasks and projects with a high standard of accuracy and presentation
-  Interacting with/leading cross-functional teams for project execution with the ability to interact positively and professionally with team members and clients from globally diverse cultural backgrounds
-  Planning, organizing, monitoring and controlling projects; ensuring efficient utilization of technical resources and appropriate mitigation of risk to achieve project objectives