Senior Quality Engineer - FDA/ISO Compliance & CI Lead

BD Mexico; Bayan Lepas; On-site; MYR 60,000 - 90,000; Full time

Job summary

BD in Penang, Malaysia is seeking a QA/regulatory-focused role to ensure compliance across design, testing and manufacturing in a fast-paced medical technology environment.

You will help optimize quality metrics, develop robust design/history files per FDA requirements, and support seamless integration of new products into BD’s manufacturing framework while upholding global quality policies.

Qualifications

• Regulatory knowledge of FDA and ISO applicable to medical devices.
• Experience with quality systems, design for manufacturability, and validation.
• Ability to develop Design/Device History Files per FDA requirements.

Responsibilities

• Maintain regulatory compliance across product design, test, and manufacturing.
• Generate process/product quality information and share with project teams.
• Improve key quality metrics and implement standardization across the organization.
• Support the integration of new products into Manufacturing/Operations.

Job description

BD in Penang, Malaysia is seeking a QA/regulatory-focused role to ensure compliance across design, testing and manufacturing in a fast-paced medical technology environment.

You will help optimize quality metrics, develop robust design/history files per FDA requirements, and support seamless integration of new products into BD’s manufacturing framework while upholding global quality policies.