QA Specialist, Baxter

QA Specialist

Baxter

Location:

Hong Kong, Quarry Bay

Category:

Quality Control

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

This role focuses on maintaining the Quality Management System and ensuring compliance with local regulations and corporate standards. Responsibilities include managing internal and external audits, handling post-market surveillance, and collaborating with global teams. The role is critical in maintaining safety standards and supporting the company's mission of saving and sustaining lives.

Job Responsibility:

Maintain Quality Management System to meet local regulation and company corporate requirements
Maintain Post-Market Surveillance, including but not limited to product complaint handling, FCA, product recall and reporting
Process on intern company system and ad hoc projects, including SOP review, product release, 3PL management, supplier management, document management, change control, internal/external audit, NCR/CAPA/SCAR
Internal and external audit management
Communication with BU and global team on a timely basis

Requirements:

Good in communication skills, responsible and self-motivated
Fluency in spoken and written English
Ability to work independently with a great team play spirit and well organized
Understanding of ISO13485 or PIC/S GMP standards

What we offer:

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Additional Information:

Job Posted:

March 21, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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