Ensure that Edwards has the key quality information necessary for regulatory compliance.
Key Responsibilities:
• Evaluate and analyze basic technical information and data related to production quality indicators, identifying trends to establish criteria.
• Compile data and generate reports for Engineering and other internal customers
• Assist with updates to Quality procedures (e.g., inspection improvement initiatives)
• Assist with developing training materials for quality system related processes
• Contribute to Quality, Engineering, and Manufacturing projects
• Other duties assigned by Leadership; Support corporate level project management, including representing the department in corporate level initiatives. Execute software validations impacting quality systems. Use JDE to put stop shipment holds on orders. ECRs)
Education and Experience:
Bachelor's Degree in Related field, 1 Year years experience Required
Additional Skills:
• Experience working in a medical device, healthcare, or a related environment preferred
• Good computer skills in MS Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Good knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
• Full knowledge of Good Documentation Practices (GDP)
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
• Ability to build stable working relationships internally
• 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
