Manager, Quality

Taipei City - Taiwan

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Imagine how your ideas and expertise can change a patients 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products 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 youll need (Required):
Bachelors 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

Required Experience:

Manager