In this role, you have the opportunity to

Developing, applying, revising, and maintaining the manufacturing quality activities.

Ensuring compliance the regulatory (FDA, CE, NMPA, PED, ASME)/standard (ISO13485) requirements are implemented correctly and followed strictly.

You are responsible for

• Responsible for driving product quality improvement in operations.

• Responsible for handling and determine Nonconformity products during manufacturing process.

• Lead the project team to workout the control point from FMEA through control plan.

• Design and Develop inspection process to cover in-process, final and package, DHR review before final release.

• Contact Window to handle customer and market quality issue compliant and feedback

• Responsible for Quality Data analysis and report provide by weekly/monthly/Quarterly. 

• Conduct Process Audit to drive continue improvement in ops.

• Provide training on Quality Assurance related topics

• Participate and support the Process Validation execution as needed.

• Participate and supporting the external and internal Audit.

• Other tasks assigned by manager.

You are a part of

• Directly reports to Manufacturing Quality Manager

To succeed in this role, you should have the following skills and experience

• Bachelor Degree Or Above, major in Mechanical