Quality Engineer

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

Job Description: Quality Engineer (Cleaning, Packaging & Sterilization)

About the Client

We are currently partnering with a premier, internationally recognized OEM contract manufacturer of high-quality medical devices and orthopedic implants. Located in Kamunting, Perak, my client provides end-to-end manufacturing solutions for top-tier medical brands worldwide. Their state-of-the-art facility is equipped with expansive cleanrooms to ensure all products meet the absolute highest global safety standards. They are looking for top talent to join their team and drive continuous innovation in patient care.

Job Summary: seeking a highly skilled Quality Engineer with a specialized background in cleaning, packaging, and sterilization validation. In this role, you will be crucial in ensuring that their orthopedic implants and medical devices maintain strict compliance with FDA, NMPA, and ISO 13485 regulatory requirements. You will oversee the validation lifecycle of cleaning processes, packaging integrity, and sterilization methods to ensure product safety and efficacy.

Key Responsibilities

• Validation Leadership: Lead the validation (IQ/OQ/PQ) for cleaning processes, purified water systems, and sterilization equipment. You will manage the entire lifecycle of this equipment to ensure it remains in a validated state.

• Packaging & Sterilization QA: Lead the validation of finished product packaging processes, which includes packaging material compatibility, seal integrity testing, and transportation simulation. You will also validate and monitor sterilization processes (such as ethylene oxide and radiation).

• Regulatory & Technical Documentation: Ensure strict compliance with FDA, NMPA, ISO 13485, and other regulatory requirements. You will prepare and maintain technical documents, SOPs, validation protocols, and risk assessment files for audits.

• Root Cause Analysis & Continuous Improvement: Monitor the stability of cleaning, packaging, and sterilization processes. You will lead deviation investigations, conduct root-cause analysis, and drive continuous improvement projects to enhance process reliability and compliance.

• Consumable Management: Manage the lifecycle of cleaning-related consumables (e.g., detergents, filter bags, ultrasonic baskets), from evaluation and incoming validation to performance monitoring.

• Cross-Functional Collaboration: Partner collaboratively with R&D, quality, and production departments to support process development and transfer during new product introductions (NPI).

Qualifications & Requirements

• A Bachelor's degree or higher in Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or a related field.

• Preferably 5 years of experience in medical device process engineering or validation, with at least 2 years specifically focused on cleaning processes for orthopedic implants.

• A deep understanding of the entire manufacturing process for orthopedic implants, including upstream machining processes and contaminant characteristics.

• Proficiency in the cleaning validation lifecycle, cleanliness testing methods, and sterilization process validation.

• Hands‑on experience with equipment IQ/OQ/PQ, packaging validation standards, and utility systems (e.g., process water, compressed air).

• Language: Fluent in spoken and written English and Mandarin; the ability to use Mandarin as a working language for technical communication and documentation is required.

skills

no additional skills required

qualifications

no additional qualifications required

education

Bachelor Degree