Job Summary:

Assignments are done with minimal supervision. In this position, the DHR clerk is knowledgeable in basic manufacturing activities and responsible in checking/ reviewing the LHR and associated forms before submission to Document Control to meet the operational standard of Quasar Medical Singapore.

Essential Duties and Responsibilities: Include the following. Other duties may be assigned.

• Involve and support Health and Safety programs (DWB, BBS, H&S meetings).
• Ensure cleanliness of working place by performing 6S
• Involve and support in Production/ Engineering improvement project (Kaizen).
• Support day-to-day production activities
• Work with supervisor and follow up status of DHR base on Shared Master Delivery Schedule file to meet the lead time for DHR reviewing
• Work with supervisor to align and meet the target for DHR KPI with Quality
• Work with supervisor to develop process improvements to improve workflow efficiency, schedule and strategy to avoid delays.
• Communicate production GDP updates and errors to Supervisor on regular basis
• Maintain and comply with ISO13485, GMP and FDA regulations

Authority:

NA

Education/Experience and Qualifications:

·       Primary or GCE “N” level or higher, with 1+ years of assembly experience, preferably in the medical device industry.

·       Excellent communication Skills

·       Computer literate

·       Knowledgeable in GMP, ISO, cleanroom procedures, and documentation