Senior QM R&D Engineer I

Ambu; Penang; On-site; MYR 120,000 - 190,000; Full time

Job summary

Ambu A/S in Penang Global Hub is seeking a Senior QM R&D Engineer to join a dynamic, international team that supports medical professionals. The 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. You will participate in new product development, oversee design changes, manage validation activities, and

Qualifications

• Bachelor's degree in science or engineering.
• Minimum 2 years in QA or Quality Engineering.
• Knowledge of ISO13485 and ISO14971.
• Experience in product development, project management, and/or design control.

Responsibilities

• Participate in new product development and project design change for global products.
• Provide independent oversight on project/design changes deliverables; review and ensure that documents comply with regulatory requirements and quality.
• Handle change control, especially expert in process validation for global products.
• Participate in critical quality issues requiring 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 functions as identified.

Skills

Quality Assurance

Quality Engineering

Product development

Design control

Project management

ISO13485 knowledge

ISO14971 knowledge

Medical device industry

Education

Bachelor's degree in science or engineering

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

• 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

• Degree in science, engineering or equivalent.
• Min 2 years in Quality Assurance or Quality Engineering.
• Knowledge in ISO13485 and ISO14971.
• Experience in product development, project management and/or design control.
• 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.