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Quality Engineer [Biotech MNC | $6500] RRKC
$ 5,000 - $ 6,500 / month
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Job Highlights:
- Join a newly setup Biotech MNC for greater career exposure
- Up to $6,500/month + AWS + Bonus
Job Responsibilities:
- Investigate and analyze failed system modules, prepare analysis reports, and provide recommendations for continuous quality improvement.
- Support test method development and evaluate test protocols and reports to ensure compliance with regulatory requirements and quality objectives.
- Develop and apply statistical methods with appropriate risk-based justification.
- Provide input on design and manufacturing documentation, including material specifications, drawings, inspection procedures, and manufacturing processes, to ensure products are manufacturable and verifiable.
- Drive continuous improvement initiatives in design control activities and promote the use of quality tools.
- Define critical-to-quality characteristics and establish inspection plans for components, subassemblies, and finished devices.
- Identify, analyze, and propose remediation for existing and potential quality issues.
- Ensure that product modifications and updates comply with regulatory and quality standards.
- Maintain expertise in emerging regulatory requirements and quality trends related to life science products and medical devices.
- Provide risk management support across all quality subsystems.
- Perform other duties as assigned.
Job Requirements:
- Minimum of Bachelor Degree in Manufacturing, Biotechnology, or any equivalent discipline
- Minimum of 5 years of experience in the Medical Device and/or Life Science Research product industries.
- Experience in Life Sciences instrument manufacturing activities.
- Proficiency in product risk analysis and management throughout the product lifecycle.
- Understanding of process validation principles, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
If you are keen to explore this career opportunity, kindly send a copy of your resume to or simply click the button to APPLY NOW! We regret that only shortlisted applicants will be notified.
Chan Ku Ci - R22111446
EA License No: 16C8261