QAE Engineer

Ambu Sdn. Bhd.; Bayan Lepas; On-site; MYR 40,000 - 60,000; Full time

Job summary

A global medical device company is seeking a QAE Engineer for its Penang location. This position involves participating in new product development, ensuring compliance with regulatory standards, and managing quality issues. Candidates should have a degree in science or engineering and a minimum of 2 years of experience in quality assurance or engineering. Knowledge of ISO13485 is essential, along with a problem-solving mindset and accountability. Join a dynamic team dedicated to improving patient care through innovation.

Benefits

Opportunities for personal development

Wide range of employee benefits

Informal working environment

Qualifications

• Min 2 years in Quality Assurance or Quality Engineering experience required.
• Candidates from medical device industry will be given priority.
• Innovative and committed with good accountability.

Responsibilities

• Participate in new product development and project design change for global products.
• Provide independent oversight on project/design changes deliverables.
• Handle change control and process validation for global products.
• Involve in NCR/CAPA activities as required.
• Maintain Risk Management files and initiate Process Risk Evaluation.

Skills

Knowledge in ISO13485

Quality Assurance

Quality Engineering

Problem-solving

Accountability

Education

Degree in science, engineering or equivalent

Job description

Ambu A/S is currently looking for a QAE Engineer to be based in Penang Ambu Global Hub.

Join a dynamic team where your work directly supports medical professionals in solving real-world challenges. This role reports to the Manager, QM R&D and offers a unique opportunity to contribute to innovations that improve patient care. If you're passionate about making a difference and thrive in a problem-solving environment, we’d love to hear from you.

Key responsibilities

Your main responsibilities will include:

Participate in new product development and project design change for global products.

Participate and provide independent oversight on project/ design changes deliverables; review and ensure that project/validation documents comply to regulatory requirements and quality.

Handle change control, especially be the expert in process validation for global products.

Participate in the critical quality issue which required QAE attention in the project as required.

Involve in NCR/ CAPA activities as required.

Maintain the Risk Management files and initiate Process Risk Evaluation during new platform project/ design change.

Other QM R&D function, as identified.

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

Degree in science, engineering or equivalent.

Min 2 years in Quality Assurance or Quality Engineering.

Knowledge in ISO13485.

Innovative, committed with good accountability.

Candidates from medical device industry will be given priority.

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.