Epicareer Might not Working Properly
Learn More

Quality Engineer [Biotech MNC | $6500] RRKC

$ 5,000 - $ 6,500 / month

Checking job availability...

Original
Simplified

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