Engineer, Quality System
Take lead for ISO 13485 system set up and certificate. Responsible for ISO 13485 internal and external including 2nd party and 3rd party audits. Work with Molex cross function team for ISO13485 system maintenance and continue improvement .
What You Will Do In Your Role
- Follow up improvement actions, and verify the effectiveness of the actions.
- Plan and conduct ISO 13485 internal audits, follow up improvement actions, and verify the effectiveness of the actions.
- Analyse and review medical customer special requirements, raws and regulations, work with team for the gap analysis.
- ISO 13485 internal training and workshop.
- Work with team for ISO 13485 maintenance and continue improvement.
- Perform other related duties as assigned by management/ supervisor.
The Experience You Will Bring
- Degree or Diploma in Science or Engineering
- 3 years minimum in medical device industry
- ISO 13485 internal auditor certificate
- Basic computer skills Good interpersonal skills to work effectively with others.
What Will Put You Ahead
English reading, writing, speaking