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Product Complaint Engineers

Location:Central Region, Singapore
Job Type:Permanent
Posted:4th Jan 2010
Closing Date:1st Feb 2010
Posted By:Direct Advisory Group
Details:
Product Complaint Engineers

Our client is a Nasdaq listed technology company.

This position will be based in Singapore.

Responsibilities:-

-Perform product complaint investigations.
-Perform failure and root cause analysis on returned products and/or components.
-Implement corrective actions to address product failure and the root cause/s that was identified during complaint investigations.
-Develop metrics to monitor and report on complaint trends.
-Participate in risk/hazard analysis and management.
-Participate in weekly product complaint investigation meetings to provide updates.
-Distribute reports and metrics for product quality, bi-monthly compliance and management review.
-Determine if there is a need for further investigation and document results.

Requirements:-

-The ability to demonstrate good problem solving and root cause analysis skills.
-Able to develop an understanding of instrument hardware testing techniques in a manufacturing environment.
-Strong background in electro-mechanical assemblies and fabricated components. (Plastics, molding, optics, motors, cables, PCBs, etc.)
-Strong organizational, communication, analytical, and technical writing skills.
-Strong working knowledge of database, word processing, and spreadsheet programs.
-Knowledge and application of the Quality System Regulation, especially sections pertaining to complaint files (820.198) and corrective and preventive action (820.100).
-Familiarity with national (FDA) and international (EU, Australia, Canada, etc.) regulations pertaining to complaint handling and adverse events.
-Familiarity with the ISO 9001 and ISO 13485 standards for quality systems, especially sections pertaining to complaint handling and corrective and preventive action.
-BS degree, preferably in an engineering/scientific discipline, mechanical, electrical or equivalent (BSME, BSEE).
-4-6 years related experience in a regulated environment, preferably medical devices.
-Strong working knowledge of the Quality System Regulation (FDA QSR 21 CFR Part 820) and ISO 9001 and ISO 13485 quality system standards
 
Sorry! This job is no longer active as the closing date for applications has passed. You can view other vacancies from this company (if they have any) by clicking on their name above, alternatively we may have some suggestions for similar vacancies listed below that might be of interest.
 

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