Documentation Specialist

Edwards Lifesciences • Irvine, CA

1d

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. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

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 to address the diverse individual needs of our employees and their families

What This Job Offers

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