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 cutting-edge 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
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:
- Familiar with ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
- 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.
- Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices and independently develop Periodic safety update plan and reports.
- 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.
- Hands on experience in signal evaluation trending and reports, preliminary code reviews for the product complaints on periodic basis.
- Develop templates and trainings based on the quality system regulations, applicable standards and guidance.
- Independently review all deliverable

📌 Senior Quality Engineer (Nanakaramguda)
🏢 Medtronic
📍 Nanakaramguda