Quality Engineer II

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life In this exciting role as a Quality Engineer II, 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. This role reports to the Senior Quality Manager and works 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 · 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