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Senior Quality Engineer

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

Our client is a Nasdaq listed technology company.

This position will be based in Singapore

Responsibilities:-

-Serve as a team member to provide quality engineering expertise to continuous improvement teams and manufacturing support.
-Maintain company compliance of FDA Quality System Regulations and ISO 13485 standards.
-Conduct failure and hazard analysis for manufacturing support and Supplier process improvement.
-Conduct internal quality and external supplier audits.
Assists in the company’s complaint and failure investigation process.
-Knowledge of basic statistical and engineering principals is essential.
-Manage test protocol & report development for validations.
-Develop inspection and process control procedures, process through document control and provide training for the procedures.
-Participate on teams responsible for the procurement and installation of manufacturing equipment and parts.
-All other duties as assigned.

Requirements:-

-Bachelors of Science or Technology in Mechanical or Electrical Engineering preferred.
-Demonstrated working knowledge of engineering and mechanical aptitude required.
-Minimum of 5 years in the Medical Device Industry.
-Experience with FDA and ISO inspections and registration is a plus.
-Effective verbal and written communication skills;
-Ability to communicate at multiple levels of an organization;
PC skill, word processing, spreadsheet, database;
-Ability to organize and judge priorities;
-Ability to generate and maintain accurate records.
-Knowledge of statistical software packages such as Statgraphics and Minitab
-Knowledge of Six Sigma is a plus
 
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