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:
• Responsible for post market surveillance activities to fulfil region regulation requirement, including proactive monitoring and analysis of customer complaint trending, etc.
• Maintain an accurate Regional Supplier Management file (SQR) in a timely and compliance manner and to facilitate Supplier SCAR/SNED in IQVIA. Trend and analyze supplier performance to deliver monthly dashboard reporting and actionable insights.
• Analyze and trend QMS performance data to provide inputs for APAC countries’ management reviews and other performance trend analysis.
• Develop, lead, and/or contribute to the implementation of proposed modifications to resolve open issues, as a part of cross-functional / project team, to bring the process knowledge.
• Other incidental duties: Implement continuous improvement program or project assigned by manager.
What you'll need (Required):
• Bachelor's Degree in related field , 5 years experience of previous related experience
• Experience in a quality and/or manufacturing environment in the medical device industry Preferred
What else we look for (Preferred):
• Proven expertise in MS Office Suite
• AI/ IT software knowledge e.g. Copilot studio, ERP will be a plus.
• Excellent written and verbal communication skills in Local Language including negotiating and relationship management skills
• Strong written and verbal communication skills in English
• Strong problem-solving and critical thinking skills
• Knowledge of medical devices regulations (e.g., ISO13485, Local Regulatory Requirements)
• Attention to detail
• Ability to manage competing priorities in a fast-paced environment
• Work independently on complex projects and/or lines of work and reviewed for accuracy and soundness
• Adhere to all company rules and requirements (e.g. 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
Skills Required
- Bachelor's Degree in related field
- 5 years experience of previous related experience
- Experience in a quality and/or manufacturing environment in the medical device industry
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Retirement Support — Retirement programs include a 401(k) match complemented by a separate profit‑sharing contribution. These elements add meaningful long‑term value to total compensation.
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Equity Value & Accessibility — An employee stock purchase plan with a discount and look‑back feature, alongside stock awards for eligible roles, provides notable upside. Program expansions indicate continued accessibility.
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Leave & Time Off Breadth — Time‑off policies include generous PTO, company holidays, and a year‑end holiday shutdown. These offerings enhance work‑life support when available at the site.
Edwards Lifesciences Insights
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
