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Quality Engineering Manager

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

Our client is a Nasdaq listed technology company.

This position will be based in Singapore.

Responsibilities:-

-Manage quality assurance toward achievement of quality goals. Establish and maintain company compliance to FDA QSR, ISO 13485 and related standards, regulations, and requirements.
-Develop and/or manage quality programs.
-Review data and information and make accept/reject decisions about Products, Processes, Validations, etc.
-Maintain and track quality for the purposes of analysis, control, and management reports.
-Represent the department at meetings and within project teams
-Investigate product defects, rejects and systems failures with emphasis on corrective action. provide hands-on leadership to implement failure analysis and corrective actions.
-Provide quality training as needed.
-Suggest methods for improving product quality, design, or manufacturing processes.
-Serve as a team member to provide quality engineering expertise to product development, improvement, or other teams.
-Assist with failure and hazard analysis for development projects.
-Supervise quality assurance engineers, inspectors, or other personnel.
-Other duties as assigned.

Requirements:-

-BS degree in engineering, a technical or scientific discipline; or equivalent experience.
-5-10 years experience in the FDA regulated environment
-Experience in Quality in an FDA regulated industry; experience with QSR and ISO 13485.
-Experience with FDA and ISO 13485 Certification inspections.
-Demonstrated experience managing and supervising diverse teams
-Experience with ETO sterilization methods preferred
Effective verbal and excellent technical writing skills.
-Ability to communicate at multiple levels of an organization.
-Ability to organize and judge priorities.
-Excels at generating and maintaining organized and accurate records.
-Knowledge of Engineering principles using statistics and SPC tools.
PC skill, word processing, spreadsheet, database.
-Able to work effectively in a high-stress, high-energy environment
-Able to make decisions quickly based on vague or imperfect information
 
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