Senior Specialist, 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:
• 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