Validation Engineer

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

About us:
Vital Healthcare Sdn Bhd is a Malaysia-based medical device manufacturer dedicated to hemodialysis and blood purification solutions. From our advanced facilities in Selangor, we design and produce dialyzers, blood tubing sets, fistula needle sets, and related consumables that support patients and clinicians across global markets. Our culture is quality-first, innovation-driven, and hands-on-where engineers are empowered to experiment, optimise, and deliver products that improve lives.

Why you will love working here:

Comprehensive training and development, plus mentorship.

Clear career progression and internal mobility.

Supportive leadership, open communication, and team-building activities.

Recognition programs: performance-based incentives, appreciation events, and awards.

Innovative and inclusive culture where ideas are tested, measured, and scaled.

Benefits of joining us:

Medical benefits and annual medical checkup.

Seniority reward.

Year-end salary adjustment.

Year-end bonus.

What you'll be doing

Validation and verification planning: Prepare validation and verification plans and reports, including but not limited to shelf-life verification, sterilization validation, and other validation activities required by applicable standards and regulations.

Validation execution: Coordinate and implement validation and verification activities according to approved protocols, ensuring timely completion and compliance with regulatory and quality requirements.

Validation documentation management: Establish, maintain, and update validation and verification master lists for the assigned area to ensure accurate tracking and effective document control.

Regulatory documentation support: Prepare and maintain validation and verification documents required for product registration, regulatory submissions, and audits.

Calibration management: Maintain calibration plans and equipment calibration lists, coordinate third-party calibration services, and ensure all measuring equipment remains within valid calibration status.

Deviation and CAPA support: Investigate validation deviations, document findings, and support corrective and preventive actions (CAPA) to ensure process compliance and continuous improvement.

Cross-functional collaboration: Work closely with Technical, Production, and Regulatory Affairs to support validation activities, product launches, and process changes.

What we're looking for

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

Experience: 1-2 years in a manufacturing Quality Assurance role, preferably in the manufacturing, medical device, or pharmaceutical industry. Fresh Graduates are encouraged to apply!

Process expertise: Solid understanding of Quality Management Systems, Validation Processes, and Statistical Quality Control Techniques.

Problem-solving and analytics: Proficient with quality control tools and software, such as SPC, FMEA, and Six Sigma

Language proficiency: Good command of English, Bahasa Malaysia, and Mandarin, with proficiency in spoken and written Mandarin due to business communication requirements with Mandarin-speaking stakeholders.

Vital Healthcare established its presence in Malaysia in 2014, with a state-of-the-art manufacturing facility in Kapar, Selangor. We are dedicated to producing high-quality medical devices for blood purification, serving customers worldwide.

We manufacture essential hemodialysis products, including blood tubing sets, dialyzers, bicarbonate, and AV fistula needle sets.

Quality is our top priority, as we believe consistent quality ensures the best experience for every hemodialysis patient. We are committed to improving patient health and quality of life through continuous technological advancement and strict quality control.

We welcome passionate individuals to join us!

Vital Healthcare established its presence in Malaysia in 2014, with a state-of-the-art manufacturing facility in Kapar, Selangor. We are dedicated to producing high-quality medical devices for blood purification, serving customers worldwide.

We manufacture essential hemodialysis products, including blood tubing sets, dialyzers, bicarbonate, and AV fistula needle sets.

Quality is our top priority, as we believe consistent quality ensures the best experience for every hemodialysis patient. We are committed to improving patient health and quality of life through continuous technological advancement and strict quality control.

We welcome passionate individuals to join us!

Perks and benefits Medical Miscellaneous allowance Parking Year-end bonus, Annual Salary Increment, Loyalty B