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:
• Identify, lead and provide business process improvement solutions for Quality Systems, including reviewing and approving changes to procedures, to improve operation, efficiencies, and user experience
• Act as GC APAC Supplier management Lead; providing expertise guidance and support to GC APAC to achieve compliance in Edwards Supplier Quality QMS requirements
• Manage GC APAC Supplier Quality Processes which include selection, qualification, audits, approval, communications, Non-conformance management and partners with Operations to ensure the process meets established procedures
• Partner with APAC Country Quality and commercial team - provide dashboard trending, analysis and solutions on Post Market Surveillance
• Plan Quality System projects and activities with accountability for successful completion within scope of project deliverables
• Administer and improve the Training Compliance of the GC APAC and ensure that relevant training is assigned and completed by stakeholders, which includes leadership team in the Region
• Coordinate the training/ development needs for International Quality in GC APAC with respective country leaders. Develop yearly training/ development plan and execute accordingly
• Review, identify actions and/or provide support to Quality leader holistically to achieve Metrics Target
• Train, coach, and guide lower level employees on routine procedures. Provide input and mentorship for lower level employee's development plans
• Provide input and mentorship for lower level employee's development plans
• Other incidental duties assigned by immediate superior or VP, Quality
What you'll need (Required):
Bachelor's Degree in or related field, 8 years of professional experience in Quality Required and
Experience of working in regulated industry Required
Master's Degree or equivalent Experience in a manufacturing site Preferred
What else we look for (Preferred):
• Proven successful project management skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel and Quality systems
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive knowledge in process validation and risk management
• Extensive understanding of Quality Systems, National regulatory requirements
• Extensive knowledge in ISO 13485, 21 CFR 820, 21 CFR 11, the relevant regulatory requirements in country, and all other applicable requirements.
• Experience of FDA Inspection / Local Inspection preferred
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Fluency in English language required; other additional language preferred
• 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
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.
For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
