Quality Assurance Specialist

2 days ago


Singapur, Singapore SG11 CIBA VISION Asian Mfg & Log Pte Ltd Company Full time
Quality Engineer

At SG11 CIBA VISION Asian Mfg & Log Pte Ltd Company, we are driven by our commitment to delivering high-quality medical devices that meet the needs of our customers. We are seeking a highly skilled Quality Engineer to join our team in Tuas.

Key Responsibilities:
  • Ensure that design transfer and manufacturing operation activities meet the requirements of Alcon standards, 21 CFR Part 820, Part 11, ISO 13485, the Medical Device Regulation (MDR), and other applicable regulations and standards.
  • Provide operational support for product release to ensure compliance with quality and regulatory requirements.
  • Review and approve validation protocols and reports, ensuring compliance with established procedures and sound validation methodology.
  • Provide e-compliance oversight to site CSV activities.
  • Support internal and external audits and be responsible for audit finding closure, as required.
  • Trend, analyze, and monitor key performance indicators, suggesting improvements and escalating to supervisor/management as necessary.
  • Meet quality objectives set by management and comply with Alcon, QMS, and Safety requirements.
Requirements:
  • Bachelor's degree in Science, Life Science, Engineering, or other relevant education.
  • Experience in pharmaceutical and medical device industry.
  • 1-3 years of experience in Quality Assurance or Quality Control in a Pharmaceutical and Medical Device.
  • Good knowledge of cGMPs, ISO13485, 21 CFR Part 11, and/or ISO9001.
  • Experience in validation activities.
  • Knowledge of Change Control, Document Control, Training Systems, and/or Non-conformance systems will be an added advantage.
What We Offer:
  • Opportunity to work with a leading global medical device company.
  • Collaborate with a diverse and talented team in a supportive work environment.
  • Competitive compensation package and comprehensive benefits.
  • Continuous learning and development opportunities.


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