Responsible to ensure a new model of IVD instruments production transfer, process, and improvement activities meet the QMS requirements.
Responsibilities:
- Responsible for IVD instruments process-related documentation, include SOP, WI and validation files.
- As operation representative to attend the NPI project, work with R&D Department to complete the new product design transfer
- Attend manufacturing transfer project, track and monitor progress, to ensure the project is still on schedule.
- Solve the key quality and production issues and drive continuous improvement in production.
- Lead investigation, root cause analysis and risk assessment, track the effectiveness of countermeasures.
- Support product registration activity with other department to ensure product registration and type testing on track.
- Work with R&D to write DDF, MDF and registration technical files for new products.
Qualifications:
- Minimum Bachelor degree in Electrical or related field
- Preferable 5 years of working experience in the IVD or medical device industry.
- Proficiency in English language skills (written and spoken).