Senior Quality Engineer — FDA/ISO Compliance & CI

BD; George Town; On-site; MYR 90,000 - 130,000; Full time

Job summary

BD in Penang, Malaysia, is seeking a quality/regulatory professional to maintain FDA and ISO compliance for Advanced Diagnostic Systems. You will drive product quality, participate in continuous improvement, and ensure integration of new products into Manufacturing/Operations.

Join a global medical technology leader and contribute to compliant design, manufacturing, and testing processes in a regulated environment at our Penang site.

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 (Food and Drug Administration) 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 in Penang, Malaysia, is seeking a quality/regulatory professional to maintain FDA and ISO compliance for Advanced Diagnostic Systems. You will drive product quality, participate in continuous improvement, and ensure integration of new products into Manufacturing/Operations.

Join a global medical technology leader and contribute to compliant design, manufacturing, and testing processes in a regulated environment at our Penang site.