Senior QM R&D Engineer I

Ambu A/S; Penang; Presencial; MYR 180.000 - 240.000; Jornada completa

Descripción de la vacante

Ambu A/S in Penang is seeking a Senior QM R&D Engineer to join the Global Quality Management R&D team. You will contribute to new product development, design changes, and validation activities supporting global products.

The role requires a science or engineering degree and at least two years in Quality Assurance or Quality Engineering, with knowledge of ISO13485 and ISO14971; prior medical device experience is preferred.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality Assurance

Quality Engineering

ISO13485

ISO14971

Educación

Degree in science or engineering

Descripción del empleo

Department: Global Quality Management R&D

Employment Type: Full-time

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

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.