Quality Engineer – Medical Devices, Flexible Hours

Hochuen Medical Sdn Bhd; Kulai; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading medical devices manufacturer in Malaysia is seeking a Quality Engineer to ensure the highest standards of quality and compliance for medical products. The ideal candidate will have a Bachelor's degree in Engineering or Quality Management and at least 5 years of experience in quality assurance within the medical device or pharmaceutical industry. Responsibilities include managing quality feedback, preparing reports, and leading corrective actions. The company offers competitive salary, bonuses, and opportunities for professional development.

Benefits

Competitive salary

Performance-based bonuses

Comprehensive health and life insurance

Generous paid time off

Professional development opportunities

Qualifications

• 5+ years of experience in quality engineering or assurance in medical device/pharmaceutical industry.
• Proven track record of implementing quality control systems.
• Strong knowledge of quality standards (ISO 13485, GMP).

Responsibilities

• Ensure product quality meets specifications.
• Prepare quality reports for management.
• Coordinate and manage quality feedback and issues.

Skills

Problem-solving

Analytical skills

SPC

FMEA

Six Sigma

Data analysis

Interpersonal skills

Education

Bachelor's degree in Engineering or Quality Management

Job description

A leading medical devices manufacturer in Malaysia is seeking a Quality Engineer to ensure the highest standards of quality and compliance for medical products. The ideal candidate will have a Bachelor's degree in Engineering or Quality Management and at least 5 years of experience in quality assurance within the medical device or pharmaceutical industry. Responsibilities include managing quality feedback, preparing reports, and leading corrective actions. The company offers competitive salary, bonuses, and opportunities for professional development.