Quality Control Lead - Medical Devices & ISO 13485

MeHow Medical (M) Sdn Bhd; Simpang Ampat; On-site; MYR 56,000 - 89,000; Full time

Job summary

MeHow Medical (M) Sdn Bhd in Penang, Malaysia is seeking a Quality Control Engineer to oversee product quality, lead QC inspectors, and drive continuous improvement across manufacturing processes. The role emphasizes ISO 13485 compliance, QMS knowledge, and strong problem-solving skills.

The ideal candidate will interpret engineering drawings and customer specifications, coordinate with production teams, and manage documentation to satisfy regulatory requirements.

Qualifications

• Bachelor's Degree in Engineering, Quality Management, Manufacturing, or related field.
• Minimum 2 years of working experience in a manufacturing environment.
• Knowledge of Quality Management Systems (QMS), SPC and ISO 13485 requirements.
• Experience in the medical device industry is an added advantage.
• Ability to interpret engineering drawings, specifications, and customer technical requirements.
• Strong analytical, problem-solving and root cause analysis skills.
• Knowledge of 5S practices and continuous improvement methodologies.

Responsibilities

• Monitor and ensure product quality complies with specification and quality standards.
• Manage quality control inspectors and ensure inspection activities delivered on time.
• Coordinate, lead and guide QC functions on all quality-related issues and activities.
• Document to meet ISO & regulatory requirements.
• Prepare relevant quality reports for quality meetings and management reviews.
• Work with production and project teams on internal quality activities and improvement programs.
• Handle acceptance/reject/limit samples for production references.
• Support customer and supplier complaints internally and ensure complaints are addressed.
• Monitor and ensure the effectiveness of ECN, FAI, and daily quality activities.

Skills

Analytical mind

Root cause analysis

Problem solving

Quality assurance

Documentation

Interpreting drawings

Education

Bachelor's Degree in Engineering, Quality Management, Manufacturing, or related field

Job description

MeHow Medical (M) Sdn Bhd in Penang, Malaysia is seeking a Quality Control Engineer to oversee product quality, lead QC inspectors, and drive continuous improvement across manufacturing processes. The role emphasizes ISO 13485 compliance, QMS knowledge, and strong problem-solving skills.

The ideal candidate will interpret engineering drawings and customer specifications, coordinate with production teams, and manage documentation to satisfy regulatory requirements.