Ensure appropriate and necessary documentation is in place to meet EW Quality System in compliance with regulatory requirements.
+ Work with key stakeholders to track labeling projects and implement Labeling into product configurations at 3PL sites.
+ 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.
+ 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.
**Consequence of Errors:**
+ Contributes to the completion of critical and complex organizational projects and goals
+ Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify
+ Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
+ Ability to build productive internal/external working relationships
+ Develops solutions to a variety of problems of moderate scope and complexity
+ Contributes to process improvements
+ 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
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan – it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Documentation Specialist, Quality
Location: USA-USA-California – Irvine
Job Number: 014177