MedTech Validation & Compliance Specialist

BD Malaysia; Kulim; On-site; MYR 120,000 - 180,000; Full time

Job summary

BD Malaysia is seeking a Validation Engineer to plan and execute validation for eDHR systems and related equipment. The role ensures compliance with FDA 21 CFR Part 11 and ISO 13485, and requires documenting performance testing to confirm system reliability.

You will collaborate with QA, IT, OT, and manufacturing teams to maintain validated states through updates, and contribute to regulatory submissions with detailed reports and SOPs.

Qualifications

• Bachelor’s degree in biomedical engineering, QA, engineering or IT.
• Hands-on experience with eDHR systems, MES platforms (Apriso preferred).
• Experience developing validation protocols (IQ/OQ/PQ) for software and equipment.
• Strong understanding of CSV principles and risk-based validation.

Responsibilities

• Validation Planning & Execution for eDHR systems and related equipment.
• Ensure validation activities meet FDA 21 CFR Part 11 and ISO 13485.
• Conduct performance testing and document results to confirm system functionality.
• Collaborate with QA teams to align validation with quality goals and audits.
• Document and report validation results and support regulatory submissions.

Skills

Validation planning

Regulatory compliance

Data integrity

Cross-functional collaboration

Documentation

Education

Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology

Tools

Apriso MES

Job description

BD Malaysia is seeking a Validation Engineer to plan and execute validation for eDHR systems and related equipment. The role ensures compliance with FDA 21 CFR Part 11 and ISO 13485, and requires documenting performance testing to confirm system reliability.

You will collaborate with QA, IT, OT, and manufacturing teams to maintain validated states through updates, and contribute to regulatory submissions with detailed reports and SOPs.