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:
• DC Quality Management
a) Product inspection and release products, including imported finished goods, products after over labelling process and returned products
b) Audit/monitor 3PL quality compliance level, as well as daily quality performance
• Post Market Quality Assurance
a) Be responsible for product complaint and MDR management, including following up complaint investigation, prepare customer response letter in local language and report ADE to competency authority according to MFDS regulation
b) Execute post market related data analysis and work with cross functional team with regards to escalated complaints
c) implement Quality hold, Field action and Recall, including operations in JDE system. Act as local FCA coordinator
• Quality Management System
a) Execute and support on NCR and CAPA investigation and implementation
b) Support on Quality management system operation to be complied with MFDS regulatory and Edwards’ requirements, including document control, record control, change control and training
c) Training assignment support and RBM management
• Other duties assigned by Leadership (Identify basic problems with processes, procedures, and/or practices, and recommend solutions, including devising new approaches to problems encountered)
What you'll need (Required):
Bachelor's Degree or equivalent in Related field, 1 Year of previous related experience Required
What else we look for (Preferred):
• 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
• Basic knowledge of medical terms
• Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
• Ability to manage confidential information with discretion
• Attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment with guidance
• 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 internal/external 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
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
