SeniorQualityEngineer

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** As Senior Quality Engineer prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements. serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices. **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. * Drafting and authoring PSUR or CER documents. * 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. * Develop templates and training based on the quality system regulations, applicable standards and guidance. * Independently review all deliverables to ensure compliance with development process and the standard. * Collaborates with engineering, regulatory affairs and manufacturing functions to ensure submission of safety reports. * Deliver presentations and training to the QA organization on status and issues of assigned projects. * Participate when appropriate in audits. **Required Knowledge and Experience** : * BE/BTech with 8 to 12 years of experience in Risk Management experience. * Experience on PSUR or some in Post market quality experience. * Clinical medical writers. * Signal Evaluations. * Hands on experience on EU MDR. * Strong communication. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by e