Senior Quality Engineer: Regulated MedTech & Compliance

BD Malaysia; Bayan Lepas; On-site; MYR 120,000 - 190,000; Full time

Job summary

Waters is seeking a Regulatory/Quality role based in Penang, Malaysia. The position focuses on maintaining FDA and ISO regulatory compliance across product development, with emphasis on design history files and risk documentation, supplier audits, and change control.

You will contribute to continuous improvement within Advanced Diagnostic Systems and ensure alignment with manufacturing and operations. The successful candidate will work in a regulated, high-volume testing environment, interfacing

Qualifications

• Experience with FDA and ISO regulatory requirements in medical devices.
• Knowledge of Design History Files and risk/environmental documentation.
• Experience with supplier auditing and SCAR management.
• Familiarity with change control and deviations.

Responsibilities

• Maintain FDA and ISO regulatory requirements across development.
• Generate QC data (CTQ indices) and share recommendations with teams.
• Improve key quality metrics such as First Pass Acceptance and NCs.
• Develop programs for continuous improvement in Advanced Diagnostic Systems.
• Support integration of new products into Manufacturing/Operations.
• Ensure compliance with policies and facilities requirements.
• Develop and maintain Design/Device History Files per FDA.
• Understand Quality Systems and risk/environmental files.
• Supplier auditing and SCAR management and resolution.
• Manage deviations and change control.
• Other duties as assigned.

Job description

Waters is seeking a Regulatory/Quality role based in Penang, Malaysia. The position focuses on maintaining FDA and ISO regulatory compliance across product development, with emphasis on design history files and risk documentation, supplier audits, and change control.

You will contribute to continuous improvement within Advanced Diagnostic Systems and ensure alignment with manufacturing and operations. The successful candidate will work in a regulated, high-volume testing environment, interfacing