Quality Engineer: Cleaning, Packaging & Sterilization Lead

Randstad Malaysia; Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Randstad Malaysia is seeking a Quality Engineer with a specialized background in cleaning, packaging and sterilization validation for medical devices and orthopedic implants. You will lead the validation lifecycle and ensure compliance with FDA, ISO 13485 and other global regulatory standards.

You will collaborate with R&D, quality and production teams to support process development, transfer during NPI, and supplier interactions, while driving continuous improvement and packaging integrity

Qualifications

• Bachelor's degree required in Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.
• At least 5 years in medical device process engineering or validation, with at least 2 years focused on cleaning processes for orthopedic implants.
• Strong understanding of the manufacturing process for orthopedic implants, including upstream machining and contaminant control.
• 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).
• Fluent in English and Mandarin; Mandarin used for technical communication and documentation.

Responsibilities

• Validation Leadership: Lead the validation (IQ/OQ/PQ) for cleaning processes, purified water systems, and sterilization equipment.
• Packaging & Sterilization QA: Validate finished product packaging processes, seal integrity testing, and sterilization processes (e.g., EO and radiation).
• Regulatory & Technical Documentation: Ensure compliance with FDA, NMPA, ISO 13485; prepare and maintain technical docs, SOPs, validation protocols, and risk files.
• Root Cause Analysis & Continuous Improvement: Monitor process stability; lead deviation investigations and drive improvement projects.
• Consumable Management: Manage lifecycle of cleaning-related consumables from evaluation to monitoring.
• Cross-Functional Collaboration: Partner with R&D, quality, and production for NPI transfers.

Skills

English & Mandarin

Education

Bachelor's degree in Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field

Job description

Randstad Malaysia is seeking a Quality Engineer with a specialized background in cleaning, packaging and sterilization validation for medical devices and orthopedic implants. You will lead the validation lifecycle and ensure compliance with FDA, ISO 13485 and other global regulatory standards.

You will collaborate with R&D, quality and production teams to support process development, transfer during NPI, and supplier interactions, while driving continuous improvement and packaging integrity