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’llbring 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
Edwards Lifesciences (NYSE: EW), 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.
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.
Contact Us
We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus
If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm.
All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
