The Documentation Associate II will be responsible for ensuring necessary documentation is in place to meet with Edwards Quality Systems requirements and is in compliance with FDA regulations. This is a rewarding opportunity working with cross functional teams, performing an essential function for development and manufacture of our life saving products. The right candidate will have opportunities for growth and career development.
Evaluate changes proposed by initiators and provide feedback.
Ensure compliance with internal procedures, coordinate and perform incorporation of approved changes to documentation (e.g. JDE data entry, incorporate red lines to word processing, accept track changes to update drawing documents) and verify correct implementation.
Review change package against governing procedures, interact with departments to complete the change package, and release final change package.
Identify opportunities for process improvement, including developing and proposing solutions, and proposing new processes and software.
Other duties include special projects, and training others.
Bachelor’s degree preferred, high school diploma or GED required.
Minimum of 5 years experience in documentation activities within medical device or pharmaceutical industry required.
Knowledge and understanding of ERP systems and document control systems required, JDE and Team Center a plus.
Demonstrated skills in decision-making, independent initiative, and ability to produce results required.
Must function well under pressure and balance day-to-day requirements with special projects.
Strong communication, project management, and interpersonal skills.
Ability to work in a fast paced and dynamic team environment
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs about 8,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
USA-California - Irvine
Edwards Lifesciences - 22 months ago
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Edwards Lifesciences has its heart in the right place. Named for the co-inventor of the first artificial heart valve, Miles...