Assembly Process Validation Engineer
Our client is an industry recognised leader in medical devices industry focusing on design, development and manufacturing of medical devices. Being a reputable industry leader worldwide, they are now looking for more process validation engineering talent to further expand their team and effectively deliver top quality products to their reputable clients.
Responsibilities
- Provide technical assessment on equipment for assembly process
- Generate and sustain Verification/Validation protocols (IQ, OQ, PQ) and documentations through the validation lifecycle
- Provide support in designing, developing, commissioning, audit and qualifying on automated manufacturing equipment/machine.
- Coordinate with various engineering team to support the new launch of assembly process from development into mass production.
- Perform in failure investigation and root cause analyses.
Skills & Qualifications
- Bachelor's degree in Medical Device Engineering/ Electrical Engineering/ Automotive engineering or related field.
- Strong data analysis skills utilizing software such as Minitab; familiar with MS office
- Basic English speaking and writing ability is required
- Knowledge of FDA, ISO, GMP rules or related regulations is a plus
- Experience with FMEA, failure analysis, automated engineering is a plus
If you are interested to learn more about the role, please apply now, or contact for more information.
