JOB SUMMARY:
Responsible to maintain Product Quality within Quasar Medical, Singapore Operations. This will include support for new product development and transfers.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following. Other duties may be assigned.
· Maintain the requirements of IS013485, GMP, FDA 820 and other applicable regulations.
· Participate in the internal and external audit programs as required.
· Supporting NC, CAPA, customer complaint activities.
· Preparing document related to product specifications, test methods, processes, validations etc.
· Supporting the data analysis process during validation.
· Responsible for the management of the equipment calibration in Quasar Medical Singapore.
· Participate in QA initiatives or cost improvement project
· Participate in new product introductions
· Other tasks assigned
SUPERVISORY RESPONSIBILITIES:
Other Quality personnel where required.
EDUCATION/ EXPERIENCE AND QUALIFICATIONS:
· Degree in Engineering or equivalent, 3 yrs of working experiences on Quality related role.
· Proper communication skills, Microsoft skills.
· Knowledge on ISO13485, FDA 820, and/or the Medical Device Directives are preferred
· Experience in Sterilization (ETO) is Added advantage.
WORK ENVIRONMENT:
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate. Controlled Environment (Class 10K/100K cleanroom) and office area.
