Documentation Specialist

Edwards Lifesciences • Irvine, CA

15h

About The Position

In this role, you will ensure appropriate and necessary documentation is in place to meet EW Quality System in compliance with regulatory requirements. How you will make an impact: 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. Coordinate and perform incorporation of approved changes to documentation (e.g. JDE data entry and verify correct implementation). Review change package against governing procedures and release final change package with increased complexity. Train team members on ECR structure and procedures. Other duties as assigned by Leadership.

Requirements

• Bachelor's Degree in related field
• 0 years’ experience of previous related experience or equivalent work experience based on Edwards criteria

Nice To Haves

• 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
• 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

Responsibilities

• 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.
• Coordinate and perform incorporation of approved changes to documentation (e.g. JDE data entry and verify correct implementation)
• Review change package against governing procedures and release final change package with increased complexity
• Train team members on ECR structure and procedures
• Other duties as assigned by Leadership

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level