Quality Engineer: Cleaning & Sterilization Validation

Randstad; Kuala Lumpur; On-site; MYR 90,000 - 150,000; Full time

Job summary

Randstad is seeking a Quality Engineer in Malaysia with a strong background in cleaning, packaging, and sterilization validation to ensure orthopedic implants and medical devices meet global safety standards.

You will lead IQ/OQ/PQ validations, manage packaging and sterilization processes, and maintain regulatory documentation while collaborating with cross-functional teams to drive continuous improvement.

Qualifications

• Bachelor's degree in Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.
• Preferably 5 years of medical device process engineering or validation, with at least 2 years focused on cleaning processes for orthopedic implants.
• Deep understanding of manufacturing process for orthopedic implants, incl. upstream machining and contaminants.
• Proficiency in cleaning validation lifecycle, cleanliness testing methods, and sterilization process validation.
• Hands-on experience with IQ/OQ/PQ, packaging validation standards, and utility systems (e.g., process water, compressed air).
• Language: Fluent in spoken and written English and Mandarin; Mandarin as working language for technical communication is required.

Responsibilities

• Lead the validation (IQ/OQ/PQ) for cleaning processes, purified water systems, and sterilization equipment.
• Lead validation of finished product packaging processes, including material compatibility and seal integrity testing; validate sterilization processes (EO and radiation).
• Ensure strict regulatory compliance (FDA, NMPA, ISO 13485); prepare and maintain technical documentation and SOPs.
• Conduct deviation investigations, root-cause analysis, and drive continuous improvement to enhance process reliability.
• Manage lifecycle of cleaning-related consumables from evaluation to performance monitoring.
• Collaborate with R&D, quality, and production during new product introductions (NPI).

Skills

English fluency

Mandarin proficiency

Education

Bachelor's degree in Mechanical / Biomedical / Chemical Engineering

Tools

IQ/OQ/PQ

Validation protocols

Sterilization validation

Job description

Randstad is seeking a Quality Engineer in Malaysia with a strong background in cleaning, packaging, and sterilization validation to ensure orthopedic implants and medical devices meet global safety standards.

You will lead IQ/OQ/PQ validations, manage packaging and sterilization processes, and maintain regulatory documentation while collaborating with cross-functional teams to drive continuous improvement.