Ensure appropriate and necessary documentation is in place to meet EW Quality System in compliance with regulatory requirements.
Key Responsibilities :
Review change package against governing procedures interact with departments to complete the change package, and release final change package.
Perform incorporation of approved changes to documentation (e.g. JDE data entry and verify correct implementation)
Participate in special projects, complete assigned tasks and deliverables
Evaluate changes proposed by initiators and provide feedback.
Other incidental duties assigned by Leadership
Education and Experience :
Bachelor's Degree in related field, 1 Year of related experience Required or
Associate's Degree or equivalent in related field, 3 years experience related experience Required
Additional Skills :
Good computer skills in usage of MS Office Suite
Good 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
Good knowledge and understanding of Edwards policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
Good 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
Adhere to compliance with internal procedures
Work is performed independently on sections of projects and / or lines of work and reviewed for accuracy and soundness
Adhere to all EHS rules and requirements 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