Senior QM R&D Engineer I

Ambu Sdn Bhd; Penang; On-site; MYR 120,000 - 180,000; Full time

Job summary

Ambu A/S is seeking a Senior QM R&D Engineer to be based in Penang Ambu Global Hub. The role focuses on quality assurance and engineering for global product development and design changes, with oversight on validation documents to meet regulatory and quality requirements.

Ideal candidates hold a science or engineering degree with at least 2 years in QA or QE, and knowledge of ISO13485 and ISO14971. Medical device experience is highly regarded as priority.

Qualifications

• Degree in science, engineering or equivalent.
• Min 2 years in Quality Assurance or Quality Engineering.
• Knowledge in ISO13485 and ISO14971.
• Innovative, committed with good accountability.
• Candidates from medical device industry will be given priority.

Responsibilities

• 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.

Skills

Quality Assurance

Quality Engineering

ISO13485

ISO14971

Education

Science or Engineering degree

Job description

Ambu A/S is currently looking for a Senior QM R&D 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 and ISO14971.

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.

About Ambu

Since 1937, breakthrough ideas have driven our work to bring efficient healthcare solutions to life within our fields of excellence: Anaesthesia, Patient Monitoring & Diagnostics and Emergency Care. Millions of patients and healthcare professionals worldwide depend and rely on the functionality and performance of our products.

We are dedicated to improving patient safety and determined to advance single-use devices.

The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our latest landmark solutions such as the aScope™ endoscope – the world’s first single-use flexible video scope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognised medico-technical companies in the world.

Our head office is situated near Copenhagen in Denmark. Ambu employs approximately 4,200 people in Europe, North America, and the Asia Pacific.

For more information, please visit www.ambu.com.