QA Associate, Dxd Hub

2 weeks ago

Singapore A*STAR Agency for Science, Technology and Research Full time

To build the capabilities needed to execute QA routines, enforcing quality and regulatory requirements in the total product life cycle of the medical device

Involve by supporting the DxD Hub QA in realizing the company?s quality strategy. This includes assist in developing and executing QA routines in product development, manufacturing and maintenance towards product safety and efficacy

**The job activities include but not limited to the list below**:
QA support for DDx team including developing WI, SOP, validation protocols and reports
Support in lab environmental monitoring
Material receiving and inspection
Equipment and software receiving and inspection process
Minutes taking
Participate in audit, when applicable
Raise NCR, conduct CAPA process
Draft/review SOP
Draft/review equipment/software validation protocol/report
Draft project document
Assist in cross division work on adhoc basis

As pre-requisite for the job activities, the following must be fulfilled

As pre-requisite for the job activities, the following must be fulfilled
- Understanding and have working knowledge on the requirement of ISO 13485 and other related standards/regulatory requirement for design and development of software as medical device
- Working knowledge of QMS and SOP related to design and development of Software as Medical Device

**Type of Employment**: Full-Time

**Work Location**: Others

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