Manager, Quality
Edwards LifesciencesTaiwan
Posted March 25, 2026
Full Time
About the Company
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.
Job Description
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.
Requirements
- 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 continous Improvement for products and Quality-related processes
- Other incidental duties
