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
Skills Required
- Diploma
- 3 years working experience in documentation
- Good written and verbal communication skills
- Knowledge of Microsoft Office applications
- Experience with PDM or PLM
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Healthcare Strength — Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
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Retirement Support — A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
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Equity Value & Accessibility — An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.
Edwards Lifesciences Insights
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
