Job Description

Quality Systems Specialist (Systems)

Join a transformative MedTech player, poised to expand in Malaysia and shape the region's healthcare ecosystem.


In this exciting role as aQuality Systems Specialist (Systems), you will be responsible for supporting the transfer of manufacturing processes and products from our established facility to the new manufacturing site. While you will ensure that quality standards and protocols are effectively applied and maintained throughout the transfer process, aligning with ISO 13485 requirements and the company's Quality Management System (QMS), you will have the unique and amazing opportunity to be a team player in a global team applying design flow down and transfer experience.

Your responsibilities may include:

Maintain quality standards for product and process transfers in compliance with ISO 13485 and QMS. Collaborate with cross-functional teams to integrate quality into all phases of the transfer plan. Define and implement inspection methods, sampling plans, and quality controls. Support validation activities including TMV and IQ/OQ/PQ, ensuring regulatory compliance. Ensure NPI transfer activities meet quality and traceability requirements. Develop and update risk management documents (PFMEA, control plans). Coordinate readiness of equipment, tooling, and inspection systems for production start-up. Analyze historical quality data to identify and mitigate risks pre-launch. Participate in readiness reviews and verification builds to meet quality and yield targets. Manage nonconformances and support CAPA processes during transfer builds. Maintain audit-ready documentation for validation, inspection, and risk activities. Apply problem-solving and continuous improvement tools throughout the transfer lifecycle. Promote First Time Quality through preventive and predictive approaches.

Essential skills and experience:

A university degree in engineering (biomedical, chemical, industrial, biotechnology, or related fields) is required and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience. Experience in regulated industries such as medical devices, pharmaceuticals, or biotechnology is necessary. Proficiency in preparing and reviewing technical documentation, including protocols, report s, and validations, is essential. Knowledge of ISO 13485 quality management system requirements must be demonstrated. A good understanding of Good Manufacturing Practices (GMP) is important. Intermediate to advanced English skills, especially for reading and writing technical documents, are needed. Clear verbal and written communication abilities are required. Experience with creating and maintaining SOPs, protocols, and technical reports is essential. A willingness to travel as per job requirements is necessary. Holding a valid passport for travel purposes is mandatory. Willingness to undertake extended overseas assignments of one month or more, if needed, is expected.

Travel Requirements

: International travel of +25% may be required during the transfer project, interacting with the sending site team and supporting key transfer activities at both sending and receiving sites.

Desirable skills and experience

:


Experience working with cross-functional teams such as production, quality, regulatory, and engineering adds value. Participation in at least one technology or process transfer project is expected. Participation in regulatory audits is considered beneficial. Knowledge of process validation activities including IQ/OQ/PQ is preferred. Experience in transferring production lines would be advantageous. Familiarity with product design documents, device master records (DMR), and design history files (DHF) Experience using quality management systems (QMS), managing CAPAs, and handling change control.

What's in it for you:

This role offers innovative projects, strong culture and excellent opportunities for career progression. Additionally, it's an opportunity to be part of a transformative greenfield project that will contribute to our client's ongoing commitment to improving healthcare globally while supporting local communities in Malaysia.

We offer a competitive package including salary, incentives, medical coverage and paid leave.