Job Description
Our Client:
Our client aim is to unleash the power of essential, standardized tools that help the life science industry develop breakthrough medicines faster and better. They are actively looking to hire a QA Engineer to join their team in Singapore.
The Responsibilities:
* Manage product quality issues according to the requirements of the Quality System
* Analyse quality monitoring data and trend performance to drive product quality improvement in collaboration with Engineering and Manufacturing
* Review batch and quality records and approve QA release for finished goods
* Review records of Non-conformances to ensure proper documentation of disposition, investigation results and follow up of actions
* Participate in investigation and implementation of corrective and preventive actions for non-conformities or the other non-compliance issues in manufacturing or quality system processes and follow up on proper closure with verification of effectiveness
* Participate in internal audits
* Support activities to ensure successful transfer of new products into manufacturing
* Support Document Control/ Quality System activities using eQMS software
* Develop and maintain procedures and support other duties as assigned
The Requirements:
* Bachelor's Degree in Engineering, Science, Biotechnology, or related fields
* Minimum 2- 3 years' experience in QA in medical device manufacturing or related industry
* Knowledge and understanding of ISO 13485 quality system requirements
* Knowledge of manufacturing processes and process control principles; including FMEA, problem solving tools, statistical methods
* Good communication and interpersonal skills
Disclaimer: The Company complies with the Tripartite Guidelines on Fair Employment Practices (TGFEP), including the prevailing guidelines on recruitment. All qualified applicants will be considered for the position regardless of their age, race, religion, nationality, marital status, or family responsibilities. A more detailed discussion of the TGFEP is available on the Tripartite Alliance for Fair and Progressive Employment Practices (TAFEP) website at https://www.tal.sg/tafep.