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.

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. You will also ensure that Edwards has the key quality information necessary for regulatory compliance.

How you will make an impact:

• Evaluate and analyze moderately complex technical information and data related to production quality indicators, identifying trends and driving factors, and recommending course corrections. Draft presentations and present summaries of trends, potential root causes, and recommended course corrections
• Draft updates to Quality procedures (e.g., inspection improvement initiatives), and conduct reviews to finalize procedures
• Contribute process knowledge to, and develop proposed modifications to resolve open issues on Quality, Engineering, and Manufacturing projects, as part of cross-functional technical groups
• Develop technical justifications and other content for Engineering Change Requests (ECRs) submissions
• Compile data and generate reports for Engineering and other internal customers
• Develop and present training materials for quality system related processes
• 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)
• Support dashboard/tool development
• Identify data needs across department and develop solutions

What you'll need (Required):

Bachelor's Degree in Related field

3 Years’ experience related experience

• Experience working in a medical device, healthcare, or a related environment

What else we look for (Preferred):

• Good computer skills in MS Office Suite
• Good written and verbal communication skills including negotiating and relationship management skills
• Good problem-solving and critical thinking skills
• Moderate knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
• Full knowledge of Good Documentation Practices (GDP)
• Good understanding of quality regulations
• 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 inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• 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