Support DxD Hub in realizing quality strategy; this includes assist in developing and executing operation routines in product development, manufacturing and maintenance towards product safety and efficacy.
Comply with relevant regulatory requirements in technical regulations and environmental requirements
The job activities include but not limited to the list below:
- Manage lab inventory, including purchasing and maintaining the critical stock level
- Management of facility
- Support in lab environmental monitoring
- Material receiving and inspection
- Equipment and software receiving and inspection process
- Draft/review SOP
- Minutes taking
- Participate in audit, when applicable
- Raise NCR, conduct CAPA process
- Draft/review equipment/software validation protocol/report
- Assist in cross division work on adhoc basis
As pre-requisite for job activities, good understanding and working knowledge on the requirement of ISO 13485 and other related standards/regulatory requirement for design and development of medical devices including software as medical device would be an advantage.
