United States of America
We have a great client in the greater Longview, TX area in need of a Quality Engineer who has experience and skill in driving standardization, consistency and improvement of quality systems and GMP’s across all shifts in their functional area of responsibility, including special projects. This position is a key leader who provides direction, support, leads projects, drives consistency, and leads problem solving for areas associated with plastics injection molding equipment related to Medical Device Quality Systems. Candidate is responsible to lead the Quality Assurance & Medical Device standardization efforts within the Plant as designated.
DUTIES AND RESPONSIBILITIES:
This position will be responsible for the quality process including critical process characteristics, standards, audits, complaint resolutions, training and laboratory functions related to FDA 21 CFR 820 ISO 13485:2016.
• Integration of quality systems to ensure a common quality system throughout the North American Plant locations.
• Provide manufacturing personnel with quality systems and tools to allow effective evaluation of products and processes.
• Ensure the application of advanced quality tools to provide process improvement to the manufacturing group.
• Ensure that quality tools and system training are adequate to meet the company’s medical device quality goals.
• Formulate and maintain accurate Quality Documentation including policies and procedures.
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