Senior Quality Engineer – FDA/ISO Compliance

Becton, Dickinson and Company; Bayan Lepas; On-site; MYR 180,000 - 260,000; Full time

Job summary

Waters Corporation in Penang, Malaysia is seeking a quality engineer to maintain FDA and ISO regulatory requirements across product development and manufacturing. You will drive design for manufacturability, investigate customer complaints, and oversee assembly, test, inspection and validation throughout the life cycle.

You will develop CTQ metrics, lead continuous improvement programs, and ensure compliance with QMS, risk management, and change control, while supporting new product

Qualifications

• Keeps FDA and ISO regulatory requirements current across development and manufacturing.
• Generates quality information (CTQ indices) to guide decisions and improvements.
• Drives improvements in key quality metrics (FPA, NCM, complaints).
• Develops programs for continuous improvement and standardization across the Advanced Diagnostics Systems.
• Supports integration of new products into Manufacturing/Operations.

Responsibilities

• Ensures compliance with regulatory policies, design history files, and risk/environment files.
• Manages deviations and change control for products; handles supplier audits and SCARs.
• Maintains documentation and adherence to Quality Systems across the product lifecycle.

Skills

Regulatory compliance

FDA

ISO

Quality systems

Process improvement

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Waters Corporation in Penang, Malaysia is seeking a quality engineer to maintain FDA and ISO regulatory requirements across product development and manufacturing. You will drive design for manufacturability, investigate customer complaints, and oversee assembly, test, inspection and validation throughout the life cycle.

You will develop CTQ metrics, lead continuous improvement programs, and ensure compliance with QMS, risk management, and change control, while supporting new product