Edwards Lifesciences Document Control, Senior Coordinator in Shannon, Ireland
The Company: Edwards Lifesciences is 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.
Provides clerical/administrative in support of Product Configuration Services (PCS) activities.
• Create Enterprise Change Requests (ECR) in PLM and provide basic recommendations for content
• Perform incorporation of approved changes to documentation (e.g. JDE data entry, verify correct implementation, coordinate with initiator for completion of business priorities)
• Prepare and upload electronic documentation for Enterprise Change Requests
• Participate in special projects, create and monitor tracking spreadsheets, and complete assigned tasks and deliverables
• May train on most operations to lower level staff
• Other incidental duties
Education and Experience:
Leaving Certificate requiredExperience working within a highly regulated industry, preferably medical device
• Good computer skills including MS Office Suite
• Experience with PDM (Product Documentation Management), PLM (Product Lifecycle Management) and change control preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Able to read, write, comprehend, and speak English
• Good knowledge and understanding of Edwards policies, procedures, and medical device regulations as it relates to records and documentation
• Proficiency in Microsoft Office Suite, PDM (Product Document Management) system, and Ignite
• Good written and verbal communications skills
• Good problem-solving skills
• Ability to manage confidential information with discretion
• Attention to detail
• Contacts are frequently with individuals representing other departments, and/or representing outside organizations
• Must be able to work in a team environment, including immediate supervisor and other team members within and outside of group
• Ability to build stable working relationships internally
• 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
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 13,000 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.