Senior QM & R&D Engineer – Medical Devices

Ambu

Penang

On-site

MYR 120,000 - 190,000

Full time

3 days ago

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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.