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Medical Device Quality Assurance Specialist
6 days ago
**About Us**
At CIBA VISION ASIAN MANUFACTURING AND LOGISTICS PTE. LTD., we are driven by our mission to help people see brilliantly. We innovate boldly, champion progress, and act with speed as a global leader in eye care.
As a Medical Device Quality Assurance Specialist at our Tuas facility, you will play a critical role in ensuring the design transfer and manufacturing operation activities of medical devices meet the requirements of our standards, 21 CFR Part 820, Part 11, ISO 13485, the Medical Device Regulation (MDR), and other applicable regulations and standards.
What You'll Do
- Provide operational support for product release to ensure compliance with quality and regulatory requirements.
- Review and approve validation protocols and reports to ensure compliance with established procedures and sound validation methodology.
- Provide e-compliance oversight to site CSV activities.
- Conduct quality oversight of activities related to calibration, preventive maintenance, spare part assessment, and associated deviations.
- Support internal and external audits and be responsible for audit finding closure as required.
- Work with cross-functional teams to resolve operational quality issues, trend, analyze, and monitor key performance indicators, suggest improvements, and escalate to supervisor/management as necessary.
- Identify improvement opportunities and lead/support the implementation activities to improve performance and efficiency.
- Meet quality objectives set by management and comply with Alcon QMS and Safety requirements.
- Perform any other duties assigned by Supervisor according to business needs.
Your Qualifications
- Bachelor's Degree in Science, Life Science, Engineering, or other appropriate 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.
- Have experience in validation activities.
Why Join Us
- 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.
Salary range is estimated around SGD $65,000 - SGD $90,000 per annum depending on qualifications and experience.
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