Senior Quality Engineer - Medical Devices & CAPA Leader

Intersurgical Medical Sdn Bhd; Simpang Ampat; On-site; MYR 60,000 - 90,000; Full time

Job summary

Intersurgical Medical Sdn Bhd in Penang, Malaysia, invites a Quality Engineer/Senior Quality Engineer to join our manufacturing quality team. You will oversee audits, CAPAs, DHRs and CAPA tracking to ensure products meet regulatory and customer requirements.

Candidates hold a Bachelor in Engineering or Science with at least 3 years in a manufacturing environment, preferably medical device. Strong knowledge of ISO13485, FDA/EU MDR is a plus; fluent English and Bahasa Malaysia are expected.

Qualifications

• Bachelor’s degree in engineering, science, or equivalent.
• Minimum 3 years in a manufacturing environment, preferably medical device manufacturing.
• Knowledge in ISO13485, FDA regulations, and EU MDR is an advantage.
• Technical experience in medical devices and Quality Management Systems.
• Auditing, inspections, and quality assurance experience.
• Detail-oriented, systematic, and able to work with minimal supervision.

Responsibilities

• Oversee and organize day-to-day quality staff activities for inspections and documentation.
• Supervise and coach team members; assign tasks to meet schedules and targets.
• Review DHR documentation for completeness and accuracy.
• Manage quality metrics: non-conformance, SCAR, customer complaints, CAPA.
• Drive CAPA process and root cause analysis; prepare investigation reports.
• Prepare monthly quality performance indices and coordinate quality activities with departments.
• Coordinate distribution of Device Master Records for training and assist with ECN processes.
• Assist with SOP implementation and continuous improvement.
• Perform internal and supplier audits; support external audits.
• Coordinate supplier approvals and maintain related documentation.
• Communicate with suppliers on acceptance/rejection and drive quality improvements.
• Identify opportunities to improve quality activities and cross-functional communication.
• Maintain compliance with domestic and international quality standards.

Skills

Quality assurance

Auditing

CAPA

Root cause analysis

Documentation

SOPs

Cross-functional collaboration

Problem solving

English language

Bahasa Malaysia

Education

Bachelor’s Degree in Engineering, Science or equivalent

Job description

Intersurgical Medical Sdn Bhd in Penang, Malaysia, invites a Quality Engineer/Senior Quality Engineer to join our manufacturing quality team. You will oversee audits, CAPAs, DHRs and CAPA tracking to ensure products meet regulatory and customer requirements.

Candidates hold a Bachelor in Engineering or Science with at least 3 years in a manufacturing environment, preferably medical device. Strong knowledge of ISO13485, FDA/EU MDR is a plus; fluent English and Bahasa Malaysia are expected.