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.
How you will make an impact:
• Oversee Quality system performance in Taiwan to be in compliance with ISO 13485, TWFDA regulation and Edwards Quality requirements, and ensure achievement of quality objectives.
• Act as Quality Business Partner and provide quality solutions in alignment with business sustainable growth, including developing quality initiatives, providing quality solutions and advice, promoting quality culture, connect with authorities and industry etc.
• Ensure product safety and traceability using the Local Product Quality Control and 3PL Management.
• Manage Primary Post Market Surveillance, including complaints & MDR handling, FCA, and others.
• Drive continuous improvement for products and Quality-related processes.
• Other incidental duties
What you'll need (Required):
• Bachelor's Degree in related field, 6-8 years of previous related experience Required
• Fluent oral and written English skill Required
• Quick learning and problem solution capability Required
• Experience working in multinational healthcare companies Preferred
What else we look for (Preferred):
• Proven successful project management skills
• Familiar with ISO13485 and Taiwan regulations (eg. GDP, Recall, MDR, etc)
• Solid quality audit skill
• Great business acumen and strategic thinking.
• Proven expertise in both Microsoft Office Suite, including advanced Excel
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good facilitation and presentation skills
• Recognized as an expert in own area with specialized depth and breadth of expertise within area of work in the organization
• Expert understanding of related aspects of Quality processes and/or systems, and regulatory requirements
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on projects within a specific area interfacing with project members and stakeholders
• Consult in project setting within specific Quality-related area
• 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
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.
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