Specialist, Documentation Edwards Lifesciences
Irvine, CA

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



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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