Medical Device Supplier Quality Engineer

Insulet Corporation; Gelang Patah; In loco; MYR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

Insulet Corporation in Malaysia seeks an Engineer, Supplier Quality to support supplier selection, qualification, and management, ensuring Insulet quality standards are met. You will work with suppliers and internal teams to communicate quality metrics and drive corrective actions.

Responsibilities include maintaining supplier records, auditing suppliers, CAPA initiation, and reporting supplier performance to management, while supporting Design Control and regulatory compliance with FDA/ISO

Competenze

• Bachelor's degree in science or engineering required.
• 2–5 years of quality/ supplier quality experience in medical devices.
• Experience with ISO 13485, FDA regulations and CAPA processes.
• Able to communicate across multiple levels with external partners.

Mansioni

• Support supplier selection, qualification, and management to meet Insulet requirements.
• Maintain supplier records and audit schedules; generate audit reports.
• Lead CAPA activities and drive corrective actions with suppliers.
• Communicate quality metrics via supplier scorecards and management reviews.
• Assist in internal audits and participate in design control initiatives.

Conoscenze

Quality Assurance

Supplier Quality

Auditing

Communication

Formazione

BS in Engineering

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Descrizione del lavoro

Insulet Corporation in Malaysia seeks an Engineer, Supplier Quality to support supplier selection, qualification, and management, ensuring Insulet quality standards are met. You will work with suppliers and internal teams to communicate quality metrics and drive corrective actions.

Responsibilities include maintaining supplier records, auditing suppliers, CAPA initiation, and reporting supplier performance to management, while supporting Design Control and regulatory compliance with FDA/ISO