Senior Coordinator, Documentation

Provides clerical/administrative in support of Product Configuration Services (PCS) activities.

Key Responsibilities:
Review change package against governing procedures liaise with initiator to complete the change package and release final change package
Perform incorporation of approved changes to documentation (e.g. JDE data entry verify correct implementation coordinate with initiator for completion of business priorities)
Identify improvement opportunities and participate in special projects create and monitor tracking spreadsheets and complete assigned tasks and deliverables
Create Enterprise Change Requests (ECR) in PLM and provide basic recommendations for content
Provide administrative support for audit backroom activities and ensure timely response to documentation requests for auditors during external audits
Assist in facilitating and delivering the PLM training including the training logistics (e.g. setting up training rooms preparing training materials and scheduling training invites etc.)
Provide administrative support for Change Control related report metrics consolidation and technical/process support to end users in PLM/Change Control related activities including the support and follow-up for resolution on PLM system issues
Other incidental duties (e.g. job role related and audit administrative support)

Education and Experience:
Other: Diploma 3 years working experience in documentation related function in medical device or pharmaceutical industry required

Additional Skills:
Knowledge of Microsoft office applications
Flexibility to work overtime as required
Good written and verbal communication skills and interpersonal relationship skills required
Must be able to work independently as well as in a team environment
Strict attention to detail and accuracy
Ability to work in a fast paced team environment
Ability to build stable working relationships internally
Good knowledge and understanding of Edwards policies procedures and medical device regulations as it relates to records and documentation
Experience with PDM (Product Documentation Management) or PLM (Product Lifecycle Management) preferred
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