Quality Engineer

- 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), etc with ensuring protocols, acceptance criteria, and documentation meet regulatory and QMS requirements.- Ensure quality engineering activities for NPI manufacturing transfer are compliant with quality requirement, 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, sp 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 Medtronic Performance System (MPS) principles and implement MPS tools to drive problem-solving, waste elimination, and continuous improvement throughout the product transfer lifecycle to enhance process stability, improve efficiency, and sustain high-quality output post-transfer.- Promote and ensure First Time Quality at the Source (preventive/predictive approach)