Quality Engineer

GN Group; Kulai; On-site; MYR 40,000 - 60,000; Full time

Job summary

A manufacturing company located in Johor, Malaysia is seeking a Quality Analyst. The successful candidate will be responsible for managing quality issues, conducting statistical analyses, and collaborating with cross-functional teams to ensure compliance with quality standards. A Bachelor’s degree in Science or Engineering and 3 years of experience in a quality role is required. The position calls for strong analytical skills and fluency in English, with knowledge of medical devices considered advantageous. Competitive salary and career development opportunities are offered.

Qualifications

• Bachelor’s degree/diploma in Science or Engineering discipline.
• 3 years of experience in quality field in manufacturing environment.
• Experience in medical devices is an advantage.

Responsibilities

• Handle internal and external quality issues and customer complaints.
• Participate in process or equipment validation reviews.
• Conduct statistical analysis of quality process data.
• Monitor the effectiveness of corrective actions.
• Ensure adherence to Health, Safety & Environmental procedures.

Skills

Quality analysis

Statistical analysis

Problem-solving

Communication skills

Education

Bachelor’s degree/diploma in Science or Engineering

Tools

Microsoft Office

Job description

Responsible for quality analysis set up, analysis, feedback opportunities and follow up the improvement

THE TASK

Handling of internal and external quality issues and customer complaints.

Participate in process or equipment validation review to ensure compliance with quality and regulatory requirements.

Perform batch record reviews and lead initiatives to reduce defects and customer complaints.

Conduct statistical analysis of quality process data; interpret, compile and organize results to identify opportunities for improvement.

Update and maintain quality documentation, such as Master validation plan, PFMEA, Control plan and SOPs

Work with cross-functional teams on failure investigations, including NCR, deviation, complaint and field return issues; monitor the effectiveness of the corrective actions.

Provide feedback on relevant functions for further analysis and improvement; follow up to ensure a timely and effective solution until case closure.

Authorize to place on-hold the products and stopping the production line in the event of critical quality issues or significant deviations from quality standards are detected, ensuring immediate containment to prevent release of defective products.

Ensure implementation, adherence and participation in Health, Safety & Environmental (HSE) procedures by applying to areas of responsibility.

Continuously contribute, develop and implement ideas that improve performance.

Perform other tasks assigned by the superior

THE PEOPLE

Bachelor’s degree/diploma in Science or Engineering discipline or above or meet below working experience requirements.

Mechanical or Electronic Basis preferred.

Preferably 3 years’ experience in quality field in manufacturing environment or relevant working experience, good products knowledge.

Experience in medical devices and/or knowledge of a wide range of manufacturing technologies is an advantage.

PROFFESIONAL REQUIREMENTS

Strong ability in practice and analysis.

Understand requirements of process/equipment validation

6 sigma certificates as a plus

Fluent verbal and written English

Good computer skills of Microsoft application software

Good coordination & communication skills and team spirit

High responsibility, pay attention to detail.