Job Information
Abbott Assistant QA Manager in New Taipei City, China
Main Responsibilities:*
Primary point of contact for all QA matters related to Taiwan Core Dx Representative Office
Responsible for Taiwan Core Dx Commercial Affiliates GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices) Quality activities.
Provide expertise to Taiwan Commercial Affiliates to Improve and maintain the quality system.
Accountable for Post Market activities including complaint related tasks, Recalls, Field Action, Advisory Notices etc and participate in the execution of required customer communications.
Skills & Experience Required:*
Bachelor’s Degree in Biomedical Engineering, Biochemistry, Chemistry, Pharmacy, or related science.
Bachelor`s Degree with 10+ years of relevant experience.
Master`s Degree with 8+ years of relevant experience.
Quality system discipline or equivalent would be desirable.
Quality audit experience would be desirable
Knowledge of the functional operation of IVD and/or Medical Devices and understand complex biological system.
Previous experience should demonstrate the ability to perform quality control activity and to prepare product registration documentation.
Familiarity with the Act on In Vitro Diagnostic Medical Devices, the Medical Device Act and related regulations.
ISO 13485 and GDPMD knowledge
Good communication and negotiation skill to facilitate implementation of complex technical solutions and must possess independent decision making skills.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com