- To ensure CV production and process control is sufficient, effective and compliant with quality system requirement, and provide high quality performance product to customer.
- Setup the process engineering& quality control program from product to serial production lots, according to relevant corporate product/process specification, and incoming inspection.
- Carry out the related process validation, test method validation & routine quality monitoring program.
- Establish quality specification, SOP, and production process engineering& inspection working instruction, with respect to corporate and local quality requirement.
- Train and qualify all quality control activities for all the process operators and process inspectors.
- Handling the related quality nonconformity and internal/external customer complaint investigation.
- The role may require local and international travel.
Required Knowledge/ Skills/Experience
- At least 3 years in quality control experience of manufacturing, if have quality control experience in EU/US company is preferred.
- More than 2 years working experience in GMP environment of medical industry is preferred.
- Familiar with ISO9001/13485, GMP, validation.
- Familiar with quality control statistic tools, SPC, MSA, GR&R etc.
- Good computer and software skills.
- Bachelor’s degree in science or engineering.
- Good English communication both in oral and written.
- Great systematic and logical thinking.
- Good team work spirit and coordination skills.