Taiwan Job Openings
Abbott Laboratories
Assistant QA Manager
FULL TIME
September 6, 2024
Main Responsibilities:*
Skills & Experience Required:*
- 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.
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