Impactful Validation Engineer – Medical Devices

Vital Healthcare Sdn Bhd; George Town; On-site; MYR 56,000 - 89,000; Full time

Benefits offered by this job

Medical benefits

Parking

Year-end bonus

Annual salary increment

Loyalty bonus

Miscellaneous allowance

Job summary

Vital Healthcare Sdn Bhd seeks a Quality Assurance professional to lead validation and verification activities for our blood purification devices, ensuring compliance with global standards and internal quality systems.

You will plan, execute and document validation studies, coordinate CAPA, support regulatory submissions, and collaborate with Technical, Production and Regulatory Affairs to drive product quality and process improvement.

Qualifications

• Knowledge of Quality Management Systems, Validation Processes and Statistical QC.
• Familiar with SPC, FMEA and Six Sigma methodologies.
• Good command of English, Bahasa Malaysia and Mandarin for business communications.

Responsibilities

• Prepare validation/verification plans and reports per standards and regulations.
• Coordinate and implement validation activities per approved protocols and timelines.
• Maintain validation master lists for accurate tracking and document control.
• Prepare and maintain regulatory documents for product registration and audits.
• Maintain calibration plans and coordinate third-party services.
• Investigate validation deviations and support CAPA actions.
• Collaborate with Technical, Production and Regulatory Affairs on validation activities.

Skills

Quality Assurance

Validation

Calibration

CAPA

SPC

Six Sigma

Education

Bachelor’s degree in Engineering

Biomedical Engineering

Tools

MS Office

SPC Software

Job description

Vital Healthcare Sdn Bhd seeks a Quality Assurance professional to lead validation and verification activities for our blood purification devices, ensuring compliance with global standards and internal quality systems.

You will plan, execute and document validation studies, coordinate CAPA, support regulatory submissions, and collaborate with Technical, Production and Regulatory Affairs to drive product quality and process improvement.