Quality Manager job opportunity at Edwards Lifesciences Corporation.

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DateMore Than 30 Days Ago bot
Edwards Lifesciences Corporation Quality Manager
Experience: 8-years
Pattern: full-time
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degreeOND
loacation China-Shanghai, China
loacation China-Shanghai....China

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: • Act as strategic QA Business Partner, develop and deploy quality initiatives in alignment with business growth and quality strategy • Collaborate with BUs, channels and other functions to ensure optimal quality and regulatory compliance, explore innovative solutions and drive continuous improvement • Support New Product Launch with sufficient and agile quality readiness • Respond promptly to customer feedback and inquiries • Lead FCA activities in China • Cultivate a strong quality culture, continuous enhance training and quality awareness to BU and distributors • In-depth evaluate and select distributors and ensure solid quality performance • Develop annual distributor audit plan and on-time audit closure with high quality • Other tasks assigned by the manager What you'll need (Required): • Bachelor's Degree or Equivalent in related field with 8 years of quality in commerical and/or manufacturing environment in the medical device industry Required • Experience working in MNCs What else we look for (Preferred): • Rich experience as Auditor and Lead Auditor • Proven successful project management skills • Proven expertise in MS Office Suite • Excellent facilitation and presentation skills • Excellent problem-solving, organizational, analytical and critical thinking skills • Excellent documentation, communication skills and interpersonal relationship skills including negotiating and relationship management skills • Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards • Extensive understanding of Edwards’ policies, procedures, and guidelines relevant to quality systems • Extensive knowledge and understanding of medical or pharmaceutical regulations as relating to documentation • Extensive understanding of medical devices regulations (e.g., FDA (21 CFR Part 820), ISO13485, and ISO 14971) • Ability to transfer essential knowledge and mentor other team members on specialized skills • Strict attention to detail • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization • Ability to manage competing priorities in a fast-paced environment • Ability to represent leadership on sections of projects within a specific area interfacing with project managers and quality systems team • Ability to consult in a project setting within specific sections • 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

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