Job Description

A Day in the Life As a Senior Quality Engineer you will be a key member of the Medtronic Post Market Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through gather and analyze data, write reports, and communicate with regulatory agencies on ensuring product safety. Responsibilities may include the following and other duties may be assigned Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices. Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities. Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance. Familiar with Literature review, PMCF,IMDRF coding, CAPA and NCMR. Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Deliver presentations to the QA organization on status and issues of assigned projects. Deliver trainings to departments outside of QA. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on EU MDR. Previous experience working in a cross-functional team environment. Hands-on experience on Risk Management, Design Controls for Medical Devices. Participate when appropriate in audits. Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards. Experience in collaborating with regulatory affairs teams for submission of safety reports. Required Knowledge and Experience B E or B.Tech in Mechanical/Biomedical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience. Understanding of post-market surveillance processes and adverse event reporting. Knowledge of risk management principles and hazard analysis in the context of medical devices. Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.Familiar with DMAIC or DMADV(DFSS) methodologies. Good verbal and written communication skills including plan / report development. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulation. Benefits Compensation About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here