Quality Engineer: Medical Device QA & Process Improvement

BD; Kulim; On-site; MYR 60,000 - 100,000; Full time

Job summary

BD in Malaysia is seeking a Quality Assurance professional to support new product introductions and ongoing production by developing quality plans, validation protocols, and inspection methods, while driving root cause investigations and corrective actions.

You will monitor material nonconformances, lead audits, participate in continuous improvement, and help ensure compliance with local quality policies and regulatory requirements, including change control and risk management, within a

Qualifications

• A bachelor’s degree or equivalent (required).
• Experience in medical devices or pharmaceutical industries preferred; specify product classification if possible.
• Proficiency in root cause analysis tools.
• Knowledge of statistical techniques.

Responsibilities

• Support the development and maintenance of quality plans, validation plans, and protocols for new and existing products.
• Investigate customer complaints, identify root causes, and implement corrective actions.
• Analyze inspection, process, and product data to identify problems and opportunities for improvement.
• Lead or assist in change control and risk management processes; support audits and regulatory compliance.
• Coordinate with cross-functional teams and ensure compliance with BD quality policies and safety regulations.

Skills

Project QA

Bilingual EN/MY

Analytical thinking

Team player

Data interpretation

Deadline-driven

Education

Bachelor’s degree or equivalent

Medical device/pharma industry experience (preferred)

Job description

BD in Malaysia is seeking a Quality Assurance professional to support new product introductions and ongoing production by developing quality plans, validation protocols, and inspection methods, while driving root cause investigations and corrective actions.

You will monitor material nonconformances, lead audits, participate in continuous improvement, and help ensure compliance with local quality policies and regulatory requirements, including change control and risk management, within a