Senior Quality Engineer — Medical Devices & Validation

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.

Penang

On-site

MYR 120,000 - 180,000

Full time

3 days ago

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Job summary

Boston Scientific in Penang, Malaysia, seeks a Quality representative to develop and maintain quality engineering methodologies, systems and practices aligning with BSC, customer and regulatory requirements. You will support NPD, operations or system/services teams and drive quality initiatives across the site.

Responsibilities include implementing process controls for development and manufacturing, creating procedures, and leading quality decision-making.

Qualifications

Must have at least a Bachelor's degree in Engineering, Science or related field.
At least 5 years of experience in Quality environment.
Strong skills in project management, validation, problem solving, communication, and people management.

Responsibilities

Identify and implement effective process control systems for development and manufacturing of products.
Ensure quality engineering methodologies and practices meet customer and regulatory requirements.
Create and revise departmental procedures.
Lead or contribute as a team member to quality disciplines and decisions.
Apply systematic problem-solving to identify, prioritize, and resolve quality issues.
Develop and execute testing and inspection methodologies and documentation for new/existing products.
Review and develop validation protocols and reports; support validation activities.
Interface with other engineering departments, customers and suppliers on quality issues.
Demonstrate commitment to patient safety and product quality per Quality Policy.