Senior Quality Engineer

Medtronic — Nanakramguda, Hyderabad, India

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 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

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