Senior Quality Engineer

Description

• 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

Highest qualification: University

• A university degree in engineering (biomedical, chemical, industrial, biotechnology, or related fields) is required and minimum of 6 years of relevant 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.