Ensure appropriate and necessary documentation is in place to meet EW Quality System in compliance with regulatory requirements.
* Coordinate with Global Labeling BU Project Managers to create and track PCS action plans for implementation of labeling into JDE Product Configurations at 3PLs
* Create all necessary ECRs per governing procedures, for the implementation of Intl label items into product configurations
* Implement approved items and all critical data into JDE RLRP applications in applicable Global site Branch Plants
* Audit and process change packages against governing procedures, for other IPS team members.
* Provide ECR creation, audit and implementation support for global site operational procedures and forms
* Lead special projects in collaboration with multi-functional team members; identify opportunities for process improvement including developing and proposing solutions, and proposing new processes and system enhancements.
* Train team members on ECR structure and procedures
* Solid knowledge and understanding of Edwards policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
* Solid understanding of medical device documentation development activities
* Ability to manage confidential information with discretion
* Strict attention to detail
* Ability to interact professionally with all organizational levels
* Ability to manage competing priorities in a fast paced environment
Supervision Received/Level of Independence:
* Work is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundness
* Participates in determining objectives of assignment; arranges own activities in accomplishing objectives
* Makes decisions in the face of different alternatives with guidelines that are not complete and exhaustive, and which allow room for creativity and judgement.
* Bachelor's degree in related field with 3 year of previous related experience OR Associate's degree in related field with 5 years of previous related experience required
* Good computer skills in usage of MS Office Suite
* Excellent written and verbal communication skills and interpersonal relationship skills
* Good problem-solving and critical thinking skills
* Experience with project management and project management software tools preferred
About Edwards Lifesciences
Edwards Lifesciences is an American medical equipment company specializing in artificial heart valves and hemodynamic monitoring.