Quality Engineer

1. Support new project/product development in validation activities, MSA, GR&R and establishing FMEA, Quality Plan, Inspection criteria, WI, PWI, form.

2. Promote and coordinate quality assurance efforts to ensure products conform to quality standards and meet relevant regulatory requirements.

3. Maintain and ensure processes are aligned with procedures/ work instuctions and ISO standard.

4. Lead investigation, root cause analysis, resolution and closure of complaint, NCR and CAPA.

5. Participate in Internal audit and Continuous Improvement Project.

6. Responsible for coordinating and conducting supplier audits.

7. Coordinate with external party and conducting supplier audits.

8. Lead in-house 9S audit program

9. Manage calibration program

10. Perform any duties as assigned from time to time.

Job Requirement:

• Diploma or bachelor's degree in quality or engineering
• Min 2 years experience in Quality Assurance role of Medical Device manufacturing, preferrably in plastic injection molding and extrusion.
• Familiar with cGMP, ISO 9001 and ISO 13485 and regulatory requirement, Internal Auditor certified preferred.
• 8D metholody and problem solving skill
• Good communication and presentation skill
• People management
• Good analytical skill and familiar with mini-tab
• Proficient in English and Chinese. Good eyesight

"We are seeking candidates proficient in Chinese to effectively communicate with Chinese-speaking clients."