Senior Quality Engineer

AMS; Kulim; On-site; MYR 70,000 - 90,000; Full time

Job summary

A global leader in quality engineered solutions seeks a Senior Quality Engineer to drive manufacturing process transfers at their new facility in Kulim, Malaysia. Responsibilities include ensuring compliance with ISO 13485 standards, mentoring junior engineers, and collaborating with cross-functional teams. The role requires a degree in engineering and at least 4 years of experience in regulated industries. Candidates must have strong communication skills and be willing to travel internationally. This position is fully on-site with potential remote collaboration.

Qualifications

• Minimum 4 years of relevant experience in regulated industries, or advanced degree with 0 years of experience.
• Proficient in preparing and reviewing technical documentation.
• Ability to communicate clearly in verbal and written forms.

Responsibilities

• Guide and mentor junior quality engineers and team during transfer.
• Develop and maintain quality standards complying with ISO 13485.
• Collaborate with teams to integrate quality requirements into transfer plans.

Skills

Technical documentation preparation

Communication skills

GMP knowledge

ISO 13485 knowledge

Problem-solving

Cross-functional collaboration

Education

University degree in engineering (biomedical, chemical, industrial, biotechnology)

Job description

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In this exciting role as a Senior Quality Engineer, you will be responsible for driving 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.

This role requires strong technical judgment and ownership of quality strategy during manufacturing transfer. You will be reporting to the Senior Quality Manager and work closely within a cross‑functional team including design and research, engineering, manufacturing, legal manufacturers, and supply chain to ensure successful and compliant manufacturing transfers.

This position is based fully on‑site at our new local facility. 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.

Main Responsibilities

• Provide technical guidance and mentorship to junior quality engineers and cross‑functional teams throughout the transfer process.
• Develop, modify, apply, and maintain quality standards and protocols for transferring products and manufacturing processes, ensuring compliance with ISO 13485:2016 and the company’s Quality Management System (QMS).
• Collaborate with cross‑functional teams including engineering, manufacturing, regulatory, supply chain, and suppliers to integrate quality requirements into all phases of the transfer plan, from process setup through production handover.
• Define and implement inspection methods, sampling plans, and quality controls for transferred processes, including in‑process and final inspection stages.
• Support Test Method Validation (TMV), process validation activities (IQ/OQ/PQ), ensuring protocols, acceptance criteria, and documentation meet regulatory and QMS requirements.
• Ensure quality engineering activities for NPI manufacturing transfer are compliant with quality requirements, including traceability of DOTM, process validations, etc.
• Develop and maintain process risk management documentation (PFMEA, control plans) to identify, mitigate, and monitor process risks during transfer and production ramp‑up.
• Coordinate readiness of manufacturing equipment, tooling, and inspection systems to support process qualification and production start‑up.
• Work with the sending site and local teams to collect and analyze historical quality data, defect trends, and process capability information to proactively address known risks before production launch.
• Participate in readiness reviews, special builds, and verification activities to ensure process capability, product quality, and yield targets are met.
• Review and manage quality issues (e.g. nonconformances) during transfer builds, ensuring timely closure, root cause analysis, and escalation into CAPA when required.
• Ensure audit readiness by maintaining complete, accurate, and compliant records for validation, inspection, and risk management activities.
• Apply continuous improvement principles and implement structured problem‑solving tools to drive issue resolution, waste elimination, and process optimization throughout the product transfer lifecycle.
• Focus on enhancing process stability, improving efficiency, and sustaining high‑quality output post‑transfer.
• Encourage a culture of First Time Quality at the Source, emphasizing preventive and predictive approaches to minimize defects and ensure compliance from the start.

QUALIFICATIONS SECTION

Must Have: Minimum Requirements

• A university degree in engineering (biomedical, chemical, industrial, biotechnology, or related fields) is required and minimum of 4 years of relevant experience, or 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, reports, 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.
• 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.

Preferred skills/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.
• Immediate availability or the ability to join within a short notice period is preferred.
• Previous experience collaborating with external teams from different countries.
• Cultural adaptability and experience working in multicultural environments will be valued.