1) Main tasks:
Tasks performed regularly which form the essential characteristics of the position.
Provide design Quality Assurance in project team as assigned.
Lead design transfer quality part from R&D to Plant and provide guidance to ensure successful design transfer per project pla
Responsible for CFDA license application support, specially focus on R&D preparation of GMP inspection, design transfer, DHF completeness, etc.
To be a DQA and provide Design Assurance Control for quality activities of design change control, complaint handling, CAPA, post market quality data collection and statistics after the products launched via plant.
Provide sustaining in Plant:
-Review AMD product NCs;
-Review AMD product CAPAs;
-Review AMD product design changes;
Document and provide evaluation from GRD side.
QA team interface with CS plant and cooperate closely with partners and support to produce a good quality product in site.
Support QMS Management and optimize the interface processes in practice between GRD CDC andplant, like design transfer process, design change process, complaint handling process, etc..
Support the preparation of internal and external audit.
Establishing positive and professional team culture within the team.
2) Secondary tasks:
Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position.
Proactively driving project progress for successful delivery.
Tracking and reporting of project progress.
Providing professional knowledge and experience to support product registration.
3) Miscellaneous tasks:
Tasks not performed regularly which are nevertheless a distinct part of the job, or special tasks / project work.
Coordination across multiple sites and locations.
Support other QMS tasks assigned by Quality Manager.
Closely with project teams, gather relevant information, report status.
The function incumbent reports to:
Sr. manager Design Quality Assurance & Regulatory Affairs
Important external interfaces:
•CS Quality team and Production team
• VTC and QRA team
•All of the different departments within company
Key Performance Indicators
•Design assurance activities conforms to QMS requirement, relevant regulations and standards.
•Maintaining a good quality level of products developed from CDC as DA.
•Good relationship with CS plant teams.
Authority to give instructions and make decisions
Technical and/or disciplinary authority of the function (if applicable):
•Review and approve the project / product documentation as quality assurance.
Qualifications, experience, know-how and skills critical for success*
1) Required training and education:
Bachelor degree level up in Science or Engineering
2) Required professional experience (in years):
5 years or more related experience in design assurance and QMS management of active medical device company.
Familiar with production line of active medical device.
Experience on supplier quality management is a plus.
3) Important personal qualities:
•Good communication skills
4) Other specialized knowledge:
a) Technical knowledge
•Have the knowledge of CFDA, ISO 13485, MDD and related regulations.
•Good written and oral English skill
c) IT skills
•Good at using Word, Excel, PPT, etc.
d) Product knowledge
•Basic knowledge of active medical device business
5 ) Special personal requirements:
5 days every week with special company allowance.
•trong sense of responsibilities and take ownership
•Helpful, customer-oriented, stable emotion, easy integrate into the team
•Has good communication skills.
•Pay attention to quality and details