Validation Engineer

Vital Healthcare Sdn Bhd; Klang City, Port Klang; Sur place; MYR 56 000 - 100 000; Plein temps

Avantages offerts par ce poste

Medical benefits

Parking

Year-end bonus

Annual salary increment

Loyalty program

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality Assurance

Validation

Statistical Quality Control

Problem-solving

Cross-functional collaboration

Formation

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

Outils

SPC

FMEA

Six Sigma

Description du poste

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

What can I earn as a Validation Engineer