Senior QM/R&D Engineer, Medical Devices (Global)

Ambu A/S; Penang; On-site; MYR 180,000 - 240,000; Full time

Job summary

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.

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

Degree in science or engineering

Job description

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.