Senior Quality Engineer: FDA/ISO Compliance & Process Improvement

BD; Bayan Lepas; On-site; MYR 90,000 - 120,000; Full time

Job summary

BD is seeking a Quality/Regulatory Affairs professional to join our Advanced Diagnostic Systems team in Penang, Bayan Lepas. You will maintain FDA and ISO regulatory requirements, drive design for manufacturability, and manage quality data across development and manufacturing processes.

You will lead continuous improvement programs, support new product introductions, ensure compliance with policies, and maintain Design/Device History Files in line with FDA expectations.

Responsibilities

• Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are product design for manufacturability, customer complaints, assembly and test, inspection and validation throughout the development process.
• Generate process/product quality information in the form of Critical to Quality indices and share with project team/operations recommendations and solutions to emerging issues.
• Improve key quality metrics (First Pass Acceptance, Quality Notifications and Complaint data).
• Develop department programs / processes on continuous improvement and standardization across the Advanced Diagnostic Systems.
• Supports the coordinated integration of new products into Manufacturing / Operations.
• Ensures Advanced Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
• Develop Design / Device History Files and maintain in a manner consistent with FDA requirements
• Understanding of Quality Systems and procedures, including maintaining of risk files and environmental files for the products.
• Supplier auditing and monitoring as issues arise (including SCAR management) and drive to resolution
• Managing deviations and change management/change control for the products
• Other emerging responsibilities as identified and assigned.

Job description

BD is seeking a Quality/Regulatory Affairs professional to join our Advanced Diagnostic Systems team in Penang, Bayan Lepas. You will maintain FDA and ISO regulatory requirements, drive design for manufacturability, and manage quality data across development and manufacturing processes.

You will lead continuous improvement programs, support new product introductions, ensure compliance with policies, and maintain Design/Device History Files in line with FDA expectations.