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The Biosensors International group of companies develop, manufacture and market innovative medical devices for interventional cardiology and critical care procedures. Our aim is to improve patients' lives through pioneering medical technology that pushes forward the boundaries of innovation. Read More
|Address||Blk 10, Kaki Bukit Avenue 1 #06-01/04 Kampong Ubi Industrial Estate Singapore 417942|
|Holding||No Holding Details|
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- Provide QA related support in the New Product Development & New Technology Development
- Identify Quality related requirements (sampling plan, acceptance criteria, Statistical Process Control)
- Qualification of Quality related testing equipment
- Generate or review the validation documents
- Perform or Coordinate the First Article Inspection activities with the supplier management group
- Assist in the arrangement of validation or evaluation testing
- Coordinate and follow up with periodic Risk Management for existing products
- Perform or involved in the Risk Management Activities for New Products
- Generate and update Quality Plan, lot release quality documents, in-process quality inspection/testing documents, in-coming material specs
- Conduct training pertaining to Design Control activities, Validation activities and new/updated quality related documents
- Perform or support Quality investigation
- Candidate must possess at least a Degree/Diploma in Life Sciences, Bioengineering, Biotechnology or any other related discipline.
- Candidates with knowledge related to Medical Devices, GMP experience, ISO 13485 or equivalent (ISO 9001) will be preferred.
- Knowledge of Six Sigma, FMEA, Statistical Process Control, Problem Solving Tools (5-Why or 8D with Fault Tree Analysis), Quality Auditing skill will be an added advantage
- Good command of English, both written and spoken.
- Self-motivated and able to work independently, with positive attitude and ability to approach challenges with fresh perspective
- Meticulous, Strong planning, interpersonal & organizational skills.
- Only Singaporean & SPR need apply.
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