Senior Quality Engineer - Regulatory & CI

Becton Dickinson Sdn. Bhd.; Bayan Lepas; On-site; MYR 90,000 - 130,000; Full time

Job summary

Waters invites qualified professionals to join our team in Penang, Malaysia, to uphold regulatory standards and drive quality across the product lifecycle. The role focuses on ensuring FDA/ISO compliance, improving quality metrics, and supporting new product introductions within Advanced Diagnostic Systems.

Ideal candidates will manage Design/Device History Files, maintain risk and environmental files, and collaborate with cross-functional teams to resolve issues and standardize processes.

Qualifications

• Maintain FDA and ISO regulatory requirements across product design, manufacturability, customer complaints, assembly and test, inspection and validation.

Responsibilities

• Generate Quality information like Critical to Quality indices for project teams and operations.
• Improve key quality metrics such as First Pass Acceptance, Quality Notifications, and complaint data.
• Develop department programs and processes for continuous improvement and standardization across Advanced Diagnostic Systems.
• Support integration of new products into Manufacturing/Operations.
• Ensure divisional policies and facilities comply with regulatory policies.
• Develop Design/Device History Files per FDA requirements.
• Maintain risk and environmental files for products.

Job description

Waters invites qualified professionals to join our team in Penang, Malaysia, to uphold regulatory standards and drive quality across the product lifecycle. The role focuses on ensuring FDA/ISO compliance, improving quality metrics, and supporting new product introductions within Advanced Diagnostic Systems.

Ideal candidates will manage Design/Device History Files, maintain risk and environmental files, and collaborate with cross-functional teams to resolve issues and standardize processes.