
Quality Engineer
4 days ago
The company is dedicated to providing sterile pharmaceutical ophthalmologic solutions along every step, from prevention to delivery of care at every touchpoint, advancing wellness in hospitals, clinics and home-care sectors.
**Summary**
This individual is responsible for product and process quality having excellent troubleshooting skills and be able to ensure that processes and products consistently meet established quality standards
**Responsibilities**:
- Develop and implement procedures as required by the standards and regulatory requirements for process and product control to ensure product and process validation are in compliant with cGMP, FDA 21 CFR Part 820, Part 210 & 211, EU MDR and ISO 13485.
- Provide guidance and training on documentation of process control, validation documents, change control.
- Liaise with eternal contractor on validation activities together with process owner.
- Evaluate the process and risk assessment and determine the quality and control plan.
- Monitor the process and product quality with applicable quality tool.
- Troubleshoot and propose corrective/preventive action plan.
- Any other tasks or projects that are being assigned by the immediate supervisor, as and when required.
**Requirements**:
- 2+ years of experience in quality engineering, quality assurance, or a similar role is required.
- Experience in coding and using QA software tools and processes.
**How to Apply**:
Lee Yuh Shiuan
Registration Number: R21101101
EA License Number: 18C9027
**Salary**: $3,500.00 - $4,500.00 per month
**Benefits**:
- Health insurance
Schedule:
- Monday to Friday
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