Job Description

Entity: Univac Precision Engineering Pte Ltd (a subsidiary of Venture Corporation Limited)

Location: 211 Woodlands Avenue 9 | #01-86 Woodlands Spectrum II Singapore 738960

About the Role

The successful candidate will be supporting the Quality Manager to establish and maintain an effective best-in-class Quality Management System and Processes in compliance with FDA 21 CFR Part 820 QSR, ISO 13485, and ISO 9001 quality management system standards, meeting customers as well as relevant statutory & medical device regulatory requirements.

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

• 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

Venture Corporation