Senior QM R&D Engineer — Medical Devices

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 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.