Quality Engineer — Medical Devices (ISO 13485, 6σ)

GN ReSound (Malaysia) Sdn Bhd; Kulai; Sur place; MYR 67 000 - 100 000; Plein temps

Résumé du poste

GN ReSound (Malaysia) Sdn Bhd in Kulai, Johor, seeks a Quality Engineer to drive quality management systems, inspect processes, and lead continuous improvement in manufacturing. You will handle complaints, validate processes, review batch records, and collaborate with cross-functional teams to contain issues and implement corrective actions.

The role requires a Bachelor or Diploma in Science/Engineering, 3 years in quality in manufacturing, knowledge of ISO 13485 is preferred, and fluent

Qualifications

• Bachelor degree/diploma in Science or Engineering; or equivalent
• Mechanical or Electronic basis preferred
• 3 years’ quality experience in manufacturing
• Experience in medical devices and ISO 13485 knowledge preferred
• Fluent verbal and written English
• Six Sigma certification a plus
• Good coordination and communication skills

Responsabilités

• Handle 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 effectiveness of corrective actions
• Provide feedback to relevant functions for further analysis and improvement; ensure closure of cases
• Authorize to place on-hold products and stop production in case of critical quality issues
• Ensure implementation of Health, Safety & Environmental procedures
• Contribute and implement ideas that improve performance
• Perform other tasks assigned by the superior

Connaissances

Quality management

Statistical analysis

Process validation

Document control

Team coordination

English proficiency

Formation

Bachelor or Diploma in Science or Engineering

Outils

Microsoft Office

Description du poste

GN ReSound (Malaysia) Sdn Bhd in Kulai, Johor, seeks a Quality Engineer to drive quality management systems, inspect processes, and lead continuous improvement in manufacturing. You will handle complaints, validate processes, review batch records, and collaborate with cross-functional teams to contain issues and implement corrective actions.

The role requires a Bachelor or Diploma in Science/Engineering, 3 years in quality in manufacturing, knowledge of ISO 13485 is preferred, and fluent