About the job
Venture, a public listed company in SGX, is a leading global provider of technology services, products and solutions with established capabilities spanning marketing research, design, research and development. Over the years, Venture has built know-how and intellectual property with expertise in several technology domains. These include life science & genomics, molecular diagnostics, medical devices and equipment, healthcare and wellness technology, lifestyle consumer technology, health improvement products, instrumentation, test and measurement technology, networking and communications, fintech, as well as computing, printing and imaging technology.
Headquartered in Singapore, the Group comprises over 30 companies with global clusters in Southeast Asia, Northeast Asia, America and Europe, and employs over 12,000 people globally.
At Venture, our people are our most valuable asset. We are committed to unifying culture, encouraging innovation, and harnessing the collective strengths and synergies of our human capital to deliver compelling differentiation, advancing Venture’s position as a leading global provider of technology solutions, products and services.
We’re looking to add a Quality Engineer (QMS) in Singapore. The position is based in our Univac Site at Woodlands.
As a Quality Engineer (QMS), you will:
Support the Quality Manager to establish & maintain an effective and best-in-class quality management system & processes in compliance to 21CFR Part 820 QSR, ISO 13485 & ISO 9001 Quality Management System standards, and meeting customers as well as relevant statutory & medical device regulatory requirements.
The key roles and responsibilities are as below:
- Establish, implement, and maintain quality systems in accordance with ISO standards such as ISO 13485, ISO 9001, ISO 14001, and FDA 21 CFR Part 820.
- Develop and manage internal audits and audit schedules; lead a team of auditors to ensure compliance with FDA 21 CFR Part 820 and ISO 13485.
- Promote continuous improvement in all aspects of quality matters.
- Optimize site processes to ensure high performance.
- Oversee document control functions.
- Manage operational efficiency through proactive oversight of the CAPA process.
- Initiate programs to standardize training and increase efficiency.
- Manage external audits conducted by certification bodies, regulatory agencies, or customers.
- Prepare executive presentations for management review.
- Perform any other tasks as assigned.
What skills and experiences are we looking for?
- Diploma and/or Degree in any technical disciplines with at least 3 years of QA/QC working experience in a medical related industry.
- Familiar with the Quality Management Systems requirements such as ISO9001, ISO13485, and 21CFR Part 820 QSR preferred.
- Knowledge in IATF16949 will be an advantage.
- Excellent analytical, presentation, written and verbal communication abilities.
If you embody the spirit of excellence, passion for discovery, innovation and enterprise, and the desire to make a difference in the world of technology and electronics, come join the Venture team!
Be Part of the Venture Family.
---- Communication will be extended to candidates who have successfully advanced in the selection process ----
