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Your Role:
Quality Control and Improvement
- Support MQ and SQE to conduct incoming failure parts analysis.
- Work with quality team to fulfil QMS requirement and support TUV, CFDA, and FDA audit.
Line Sustaining
- Update WI and DHR according to ECR from designer or PPC.
- Daily NC analysis, find root cause and drive improvement.
- Support change controller to execute ECO in production on time and minimize the line
- Introduce new product / new process / new part in production.
LEAN and Cost Reduction
- Continuously improve production efficiency by standardized work, line balance and automation project.
- Optimize production process and eliminate waste using lean method and tools.
- Organize and lead the lean activities and other improvement project.
Equipment Trouble Shooting and Improvement
- Familiar with electrical test platform.
- Identify opportunities to improve current equipment or create new equipment and work with R&D or supplier to realize the requirement.
- Define the URS to guide new equipment purchasing and the equipment qualification.
- Define the gauge calibration requirement.
Digital Transformation and data analysis
You're the right fit if:
B.S. or above in electrical, electronic engineering.
Familiar with AC, DC design and tuning.
Experience of X-Ray testing is preferred.
8 years of experience working in medical device manufacturing or finish medical device assembly or testing.
Familiar with FDA Quality Systems Regulations and ISO13485 Quality System.
Experience of Windchill and SAP.
Knowledge and methodology of six sigma and Lean manufacturing.
Knowledge of process verification and validation knowledge.
Knowledge of EMC and regulatory test requirement.
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