Abbott is seeking a QSR Specialist in Hangzhou, China, with a focus on managing quality assurance documentation and supporting audit readiness. The ideal candidate should have at least three years of experience in quality assurance within the medical device sector and be fluent in English
Job Summary
The role involves managing the company's documentation system to ensure all QA documents meet divisional, corporate, and regulatory requirements.
Candidates will support audit readiness activities for both internal and external audits, including training staff and guiding preparation efforts.
Responsibilities include leading or participating in CAPA projects and tracking the closure of improvements identified during audits.
Matching Summary
Match Score: 85
Abbott is seeking a QSR Specialist in Hangzhou, China, with a focus on managing quality assurance documentation and supporting audit readiness. The ideal candidate should have at least three years of experience in quality assurance within the medical device sector and be fluent in English.
Skills & Requirements
Must-have
Manage QA documentation systems
Support internal and external audits
Lead CAPA project completion
Track nonconforming situations
Fluent English communication
Nice-to-have
Six Sigma root cause analysis experience
Data analysis and statistical reporting
Continuous improvement initiatives
Electronic system record management
Key Requirements
Bachelor's degree in Engineering, Chemistry, Pharmacy, Biology, or Microbiology
At least 3 years of medical device quality assurance experience
Quality management system internal auditor certificate
Familiarity with ISO13485 standard and Chinese medical device regulations