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