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