Trainee Engineer, QA

UNIVAC PRECISION ENGINEERING PTE LTD; Singapore; On-site; SGD 56,000 - 89,000; Full time

Job summary

Venture invites an Engineer, Design (Mold Design) to join Univac Site in Woodlands, Singapore. The role focuses on supporting quality systems and regulatory compliance within a medical-device oriented environment.

You will establish and maintain ISO13485/ISO9001/ISO14001 and FDA 21 CFR Part 820 compliant processes, drive audits, CAPA, and continuous improvement while collaborating with cross-functional teams.

Qualifications

• Diploma or basic degree in a technical field with QA/QC experience in medical devices
• Strong interpersonal, communication, and analytical skills
• Knowledge of quality management systems (ISO 9001, ISO 13485, ISO 14001, and 21 CFR Part 820)
• Familiarity with IATF 16949 is an added advantage

Responsibilities

• Establish, implement and maintain quality system per ISO13485/ISO 9001/ ISO 14001, and FDA21 CFR Part 820
• Develop internal audits and audit schedule and lead a group of auditors, conduct internal audit to ensure the compliance to FDA 21 CFR Part 820 and ISO13485
• Promote continuous improvement in all aspect of quality matters
• Optimize site processes to ensure high performance
• Manage document control function
• Manage operational efficiency with proactive oversight CAPA process
• Initiated program that standardized training and increase efficiency
• Manage external audit from certification body / regulatory agency / Customer
• Prepare executive presentation for management review
• Any other task being assign

Skills

QA/QC

Quality Systems

Interpersonal Skills

Analytical Skills

Education

Diploma or Degree in Technical Discipline

Job description

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 Engineer, Design (Mold Design) in Singapore. The position will be based in our Univac Site in Woodlands.

As an Engineer, Design, 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, ISO14001 & ISO 9001 quality management system standards, and meeting customers as well as relevant statutory & medical device regulatory requirements

• Establish, implement and maintain quality system per ISO13485/ ISO 9001/ ISO 14001, and FDA21 CFR Part 820
• Develop internal audits and audit schedule and lead a group of auditors, conduct internal audit to ensure the compliance to FDA 21 CFR Part 820 and ISO13485.
• Promote continuous improvement in all aspect of quality matters.
• Optimize site processes to ensure high performance.
• Manage document control function.
• Manage operational efficiency with proactive oversight CAPA process.
• Initiated program that standardized training and increase efficiency.
• Manage external audit from certification body / regulatory agency / Customer
• Prepare executive presentation for management review.
• Any other task being assign

What skills and experiences are we looking

• A diploma and/or basic degree in any technical disciplines with QA/QC related experiencein a medical-related
• Mature team player with strong interpersonal, communication, and analytical skills
• Good knowledge of quality management systems (ISO 9001, ISO 13485, ISO 14001, and 21CFR Part 820 (QSR preferred)
• Familiarity with IATF 16949 is an added advantage

Be Part of the Global Venture Family.