Description
The Quality Engineer will have the following responsibilities:-Work with suppliers to drive corrective/preventative action based on feedback from RI and manufacturing floor
-Review/prepare test plans and reports for RI and improvement activities
-Identify and manage risk with the use of FMECA and other risk management tools for the manufacturing process
-Lead investigations for nonconforming material and implement corrective action
-Contribute to design and manufacturing documentation in order to verify that resulting products are correctly manufactured and tested
-Guide statistical aspects of test protocols and reports to ensure testing is sufficient in meeting regulatory requirements and quality objectives
The Quality Engineer must meet the following requirements:
-B.S. in Engineering or Science
-Minimum of 5 year experience in Ops/Process Quality and Manufacturing Quality Engineering in medical device industry
-problem solving skills for mechanical aptitude and methodical problem
-strong organizational and communication skills
-solid background and experience with computer skills including word-processing, database applications, spreadsheets and statistical software