Documentation Specialist

Imagine how your ideas and expertise can change a patients life. 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

Aortic stenosis impacts millions of people globally yet it often remains under-diagnosed and under-treated. 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. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring 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

What youll need (Required):
Bachelors Degree in related field 0 years experience of previous related experience or equivalent work experience based on Edwards criteria

What else we look for (Preferred):
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

Aligning our overall business objectives with performance we offer competitive salaries performance-based incentives and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California the base pay range for this position is $68000 to $96000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.