Validation Engineer

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.
• Incentive allowance.
• 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.