s www.globalchannelmanagement.com jobopeningsjobs(at)globalchannelmanagement.co mStaff Quality Engineer needs 7 years of experience at a medical or manufacturing facility or equivalent combination of education and experience. Staff Quality Engineer requires Bachelor s degree Background experience with application of software quality engineering principles in biological product manufacturing is highly desirable. Must be able to apply quality engineering critical thinking to the manufacture of biological products and manufacturing environment. Must be able to synthesize complex ideas for effective problem solving. Must be able to rapidly acquire and maintain in-depth product knowledge. Excellent written verbal communication and computer skills are essential. familiar with regulations and guidelines of all applicable Regulatory agencies such as FDA (QSR cGMP) OSHA ISO (including ISO14001) and OCD Health Safety and Industrial Hygiene. Staff Quality Engineer duties Provides manufacturing and software quality engineering expertise to projects teams in compliance with FDA ISO and CMDR regulations and Quality System Requirements. Responsible for application of Root Cause Investigation Process and Procedures. Demonstrates Technical Writing Skills (Quality Records technical memorandums procedures protocols and reports.) Demonstrates thorough knowledge and application of validation regulations and guidance documents principles techniques and procedures.
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