Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
How you’ll make an impact:
• 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)
What you'll need (Required):
• Other: Diploma, 3 years working experience in documentation related function in medical device or pharmaceutical industry required
What else we look for (Preferred):
• 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
