Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Representative position is a unique career opportunity that could be your next step towards an exciting future.
How you’ll make an impact:
- Identify opportunities for simplification to continuously improve workflow
- Collaborate internally and externally with 3PL employees to investigate non-conformities/abnormalities & perform detailed root cause analysis by utilizing appropriate system application (e.g., JDE, TeamCenter)
- Perform routine inspections and may be a second approver on material disposition as required
- Mitigate quality risk before non-conformance happens through strong partnership with 3PL personnel
- Conduct regular audits to prevent 3PL process deviations
- Monitor the data based on the complaints & trending to propose appropriate actions
- Improve and/or clarify procedures as required to reflect current practices & provide coaching/training
- Other incidental duties
What you'll need (Required):
- Holds H.S. Diploma or equivalent with 4 years’ relevant experience in quality related functions and DHR auditing; or Bachelor's Degree with 2 years' relevant experience
- Proven track record in process and product auditing, with successful contributions to process improvement initiatives
- Skilled in conducting inspections and ensuring compliance with quality standards
- Strong communication and interpersonal skills, with experience collaborating effectively with suppliers and cross-functional stakeholders
What else we look for (Preferred):
- Experience working in Distribution Centers (DCs) and pharmaceutical or similar regulated industries
- Substantial understanding of drawings and specifications in inspection
- Substantial understanding of quality system how it interacts other functions and areas within the organization
- Good computer skills including MS Office Suite, JDE
- Ability to interact professionally and proactively escalate issues
- Substantial problem-solving, and critical thinking skills
- Substantial knowledge of operations
- Attention to detail
- Must be able to work in a team environment under minimum supervision.
- 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
Top Skills
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
