Quality Systems Engineer

5 days ago


Woodlands, Singapore Venture Corporation Limited Full time

**About the Role**

The key responsibilities are as below:

- Establish, implement, and maintain Quality Management System as per the standard below:

- ISO 13485
- ISO 9001
- ISO 14001
- FDA 21 CFR Part 820
- Develop internal audits and audit schedules
- Lead a group of auditors to conduct internal audit to ensure compliance of FDA 21 CFR Part 820 and ISO 13485
- Promote continuous improvement in all aspects of quality matters
- Optimize site processes to ensure high performance
- Manage document control function and operational efficiency with proactive oversight CAPA process
- Initiate program that standardizes training and increases efficiency
- Manage external audits from certification body/regulatory agency/customer
- Prepare executive presentation for management review
- Any other duties as assigned

**About You**
- Diploma in any relevant discipline with 3 years of QA/QC experience in a medical-related industry
- Understand the process validations and risk management analysis requirements for the medical industry.
- Familiar with the requirements of Quality Management Systems such as ISO 13485, ISO 9001, and 21 CFR Part 820 QSR
- Knowledge of IATF 16949 will be an advantage


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