Quality Assurance Specialist

Overview:

ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

Job Summary:

• Maintain and improve the quality management system (QMS) and Standard Operation Procedures (SOPs), implement per company quality management guidelines and goals, make the Quality system work efficiently.

• Implement Company business philosophy and operating principles. Understand QMS requirement from 1) corporation; 2) Applicable local regulatory/laws; 3) company operations.

• Be responsible for the implementation and execution of activities that are associated and relevant to company internal audit and supplier quality audit tasks and other tasks that may support and enhance the safety and integrity of Company operation.

• Be responsible to the QMS contact person with corporation and procedures change analysis from corporation to China QMS impact.

Responsibility

• Work closely with each business unit and functional team, improve and maintain company quality system structure, procedures, work instructions and quality records to meet corporation and relevant law and regulatory requirements.

• Ensure that quality policies and procedures are coordinated and followed in the areas of Complaint Handling and Quality Assurance.

• Analysis Corporation procedures change impact to China QMS and business, collect related regulatory requirement, lead regulatory update requirements gap analysis.

• Lead internal audit and supplier audit, coordinate audits/visits by business units and regulatory authorities.

• Responsible for Post-market surveillance and meeting the requirement of China regulation.

• Identify the QMS training matrix per job title, lead regulatory and QMS training.

• Collect and perform quality performance measurements, data analysis and report monthly, assist to organize and conduct company Quality Management Review.

• Proactively participant medical device law and regulatory knowledge learning via various way (e-learning, classroom training, self-learning_

• Maintain and update GSP licenses accordingly.

• Cooperate with Corporation to ensure UDI are compliant with applicable regulations and support business needs for UDI related matters.

• Other related tasks assigned by line manager.
   

Required/ Preferred Education and Experience

• Bachelor degree or above, major in science or engineering, medical device is preferred.

• 4+ years experience in quality compliance or related areas in medical device, experience on both GSP & GMP is a plus.
   

Skill Requirements:

• Fluent in Mandarin and English  

• Excellent verbal & written communication skills.

• Strong ethics & professional integrity required.

• Organised, results-oriented and able to work under pressure.

• Proficient at problem solving.

• Proficient with China GSP, post-market surveillance, recall and UDI regulations for Medical Devices.

•  Ability to lead discussions and meetings effectively.

•  Ability to meet objectives, prioritize and execute strategies in a timely manner.

•  Exceptional organizational skills and the ability to schedule tactically.