QA specialist

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Responsibilities:

Quality Assurance

• Perform and handle QA activities in general office, including but not limited to: product release, product return and repackaging related activities to ensure the compliance of GMP, GDP, Baxter’s requirement, Hong Kong and Macau regulatory requirements.
• Handle customer complaints effectively (including but not limited to: complaint sample handling), ensure timely closure and escalation of quality incident and maintain customer satisfaction according to Baxter’s requirement. Prepare complaint investigation report. Monitor and review complaint metrics against targets to provide oversight for improvement.
• Coordinate cross-functional team and 3rd party’s warehouse to prepare internal audit and DH inspection. 
• Manage supplier qualification process. Conduct audit to 3rd party warehouse as an audit team member. Coordinate with cross-functional team and regional Supplier Quality to ensure Baxter’s requirement is met. 
• Support to manage 3rd party’s and distributor’s warehouse performance.
• Ensure implementation of Baxter Quality Management System at local level includes document control management.
• Support for NCR/ CAPA and change control.
• Handle ad hoc projects as assigned by QA Lead.
• Tracking regulation issue and update for medical device MDR.
• Maintain an efficient MDR system in compliance with the local authority’s regulation and Baxter Global Requirements.
• Provide MDR awareness training to all staff and vendor in Baxter Hong Kong office.
• Handling MDR reporting and submission according to Baxter and Hong Kong regulatory requirements
• Track MDR cases and perform case follow-ups as needed.
• Support Quality documents review / control.

Qualifications:

• Bachelor degree or above in related scientific discipline
• Minimum 2 years of relevant experience in pharmaceutical or medical device industry
• Ability to work independent with a great team play spirit and well organized.
• Fluency in spoken and written English, Cantonese and Mandarin.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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