Job Directory Edwards Lifesciences Specialist, Documentation
Edwards Lifesciences

Specialist, Documentation Edwards Lifesciences
Irvine, CA

Edwards Lifesciences is an American medical equipment company specializing in artificial heart valves and hemodynamic monitoring.

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About Edwards Lifesciences

Job Description

Role Purpose:

Ensure appropriate and necessary documentation is in place to meet EW Quality System in compliance with regulatory requirements.

Key Responsibilities:

* 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



#LI-EW1

#AS

Current Knowledge/skill/requirements:

* 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.



Typical Education/Experience:

* 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.

Size
12800 employees
Edwards Lifesciences

1 Edwards Way

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