Documentation Specialist

Overview

We recently announced plans to expand in Spain by building a new, state-of-the-art manufacturing plant in Moncada, Valencia. When it becomes operational in 2026, the plant will manufacture Edwards' surgical and transcatheter heart valve replacement technologies and will join a global network of more than 16,000 talented team members and five other production plants. Our new facility in Moncada will welcome up to 1,500 dedicated team members by 2029 across manufacturing, engineering, and several other professional career paths.

Hiring for professional positions has started and will continue through the winter and early spring, with specialized training for manufacturing hires beginning in the fall of 2025.

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

• Evaluate changes proposed by initiators and provide feedback and recommendations for improvement and compliance

• Lead special projects (e.g., documentation remediation) in collaboration with team members; identify opportunities for process improvement including developing and proposing solutions, and proposing new processes and system enhancements.

• Support users by responding to inquiries, addressing concerns, and guiding users through product features and troubleshooting step

• Review change package against governing procedures and release final change package by incorporating the approved changes to documentation (e.g. JDE data entry and verify correct implementation)

• Lead special projects (e.g., documentation remediation) in collaboration with team members; identify opportunities for process improvement including developing and proposing solutions, and proposing new processes and system enhancements.

• Deliver training sessions for new and existing users, as well as new team members

• Support archiving activities with document revision for record destruction, etc.

• Other duties as assigned by Leadership

• Bachelor's Degree in related field, 3 years of previous related experience; or

• Associate's Degree or equivalent in related field, 5 years of previous related experience

• Fluent in Spanish & English

• 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

• 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

• Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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