Manager, Quality
求人内容
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 strategic QA Business Partner, develop and deploy quality initiatives in alignment with business growth and quality strategy
• Support New Product Launch with sufficient and agile quality readiness
• Develop quality initiatives, provide quality solutions and advice for business initiatives
• Cultivate a strong quality culture, continuously enhance training and quality awareness to BU and distributors
• Respond promptly to customer feedback and inquiries.
• Manage Local Product Quality Control and 3PL Management to ensure product safety and traceability
• Oversee product quality related pre-market and post-market processes, identify and mitigate potential risks
• Monitor 3PL quality performance, identify any gaps and drive solutions for improvements
• Maintain and enhance local product inspection and release process to prevent any defective products released to the market
• Manage local Q hold and collaborate with relevant local stakeholders to mitigate the impact (e.g. Supply Chain, Business and Regulatory Affair.)
• Manage Change Control activities with 3PL and local stakeholders
• Act as QA contact for local regulatory authority, lead FCA activities
• Drive continuous Improvement for products and Quality-related processes
• Other incidental duties
応募条件
• 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
私たちについて
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives.
Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
Edwards Lifesciences (NYSE: EW), 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. 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.