Manager, Quality

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:
• 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

What you'll need (Required):
Bachelor's Degree in in related field , 6-8 years years experience of previous related experience medical device and health care Required
Fluent oral and written English skill Required
Quick learning and problem solution capablity
Experience working in multinational healthcare companies Preferred
 

What else we look for (Preferred):
• Proven successful project management skills
• Familiar with ISO13485 and Taiwan regulations (eg. GDP, Recall, MDR, etc)
• Solid quality audit skill
• Great business acumen and strategic thinking.
• Proven expertise in both Microsoft Office Suite, including advanced Excel
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good facilitation and presentation skills
• Recognized as an expert in own area with specialized depth and breadth of expertise within area of work in the organization
• Expert understanding of related aspects of Quality processes and/or systems, and regulatory requirements
• 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
• Represents leadership on projects within a specific area interfacing with project members and stakeholders
• Consult in project setting within specific Quality-related area
• Adhere to all EHS rules and requirements 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