Assoc Spec, Documentation
Edwards Lifesciences
Wet Plant, Cartago, Costa Rica
hace 5 días

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
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