Quality Engineering Technician

1 month ago


Singapore Quasar Medical (singapore) Pte. Ltd. Full time

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.


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