Senior Quality Engineer-某500强德资医疗公司亚太研发中心

 

Senior Quality Engineer

 

Goal of function:

 

Design Assurance Control for designdevelopment project of PEC.COM to make sure all the development activitiesstrictly follow up CDC QMS requirements, specially focus on design transferbetween GRD CDC PEC.COM team and GMQ CS plant.

 

As a QA interface with CS plant, DesignAssurance Control for quality activities of design change control, complainthandling, CAPA, post market quality data collection and statistics after theproducts PEC.COM designs or sustains are launched in GMQ CS plant.

 

Support QMS Management and optimize theinterface processes between GRD CDC and GMQ CS plant, like design transferprocedure, design change procedure, complaint handling procedure, etc..

 

Tasks*

 

1) Main tasks:

 

Tasks performed regularly which form theessential characteristics of the position.

 

Provide design Quality Assurance in projectteam as assigned.

 

Lead design transfer quality part from CDCPEC.COM to GMQ CS Plant and provide guidance to ensure successful designtransfer per project plan.

 

Responsible for CFDA license applicationsupport, specially focus on R&D preparation of GMP inspection, designtransfer, DHF completeness, etc.

 

To be a DQA and provide Design AssuranceControl for quality activities of design change control, complaint handling,CAPA, post market quality data collection and statistics after the productslaunched via GMQ CS plant.

 

Provide sustaining in GMQ CS Plant:

 

-Review AMD product NCs;

 

-Review AMD product CAPAs;

 

-Review AMD product design changes;

 

Document and provide evaluation from GRDside.

 

QA team interface with CS plant andcooperate closely with GMQ CS partners and support to produce a good qualityproduct in GMQ CS site.

 

Support QMS Management and optimize theinterface processes in practice between GRD CDC and GMQ CS plant, like designtransfer process, design change process, complaint handling process, etc..

 

Support the preparation of internal andexternal audit.

 

Establishing positive and professional teamculture within the team.

 

 

 

2) Secondary tasks:

 

Tasks performed regularly in addition tothe main duties but which do not determine the essential character of theposition.

 

Proactively driving project progress forsuccessful delivery.

 

Tracking and reporting of project progress.

 

Providing professional knowledge andexperience to support product registration.

 

 

 

3) Miscellaneous tasks:

 

Tasks not performed regularly which arenevertheless a distinct part of the job, or special tasks / project work.

 

Coordination across multiple sites andlocations.

 

Support other QMS tasks assigned by QualityManager.

 

Closely with project teams, gather relevantinformation, report status.