Validation Engineer - Medical Devices (Fresh grads welcome)

Vital Healthcare Sdn Bhd; Klang City, Port Klang; On-site; MYR 56,000 - 100,000; Full time

Benefits offered by this job

Medical benefits

Parking

Year-end bonus

Annual salary increment

Loyalty program

Job summary

Vital Healthcare Sdn Bhd, a Malaysia-based medical device manufacturer, is seeking a Validation Engineer to drive validation and verification activities for hemodialysis products. You will plan, execute, and document validation efforts, ensuring compliance with applicable standards and regulations.

The role requires a Bachelor’s degree in Engineering Science, Biomedical, or related field, and 1–2 years in a manufacturing QA setting.

Qualifications

• Bachelor’s degree in Engineering Science, Biomedical, or related field.
• 1–2 years in a manufacturing Quality Assurance role; fresh graduates encouraged to apply.
• Solid understanding of Quality Management Systems, Validation Processes, and Statistical Quality Control techniques.

Responsibilities

• Prepare validation and verification plans and reports, including shelf-life validation and sterilization validation.
• Coordinate and implement validation activities per approved protocols with regulatory and quality compliance.
• Maintain validation/master documentation lists for traceability and document control.
• Prepare and maintain regulatory submission and audit-support documents for product registrations.
• Maintain calibration plans and coordinate third-party calibration services.
• Investigate validation deviations and support CAPA for process improvements.
• Collaborate with Technical, Production, and Regulatory Affairs to support validation and launches.

Skills

Quality Assurance

Validation

Statistical Quality Control

Problem-solving

Cross-functional collaboration

Education

Bachelor’s degree in Engineering Science, Biomedical, or related field

Tools

SPC

FMEA

Six Sigma

Job description

Vital Healthcare Sdn Bhd, a Malaysia-based medical device manufacturer, is seeking a Validation Engineer to drive validation and verification activities for hemodialysis products. You will plan, execute, and document validation efforts, ensuring compliance with applicable standards and regulations.

The role requires a Bachelor’s degree in Engineering Science, Biomedical, or related field, and 1–2 years in a manufacturing QA setting.