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 creative 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.

Monitors and analyzes product complaint trends to identify emerging quality and safety issues, enabling timely investigation, risk mitigation, and regulatory compliance.
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.
Works on post-market documents as requested and needed by the RPM teams.



This can include but not limited to signal evaluations and HHE (Health Hazard Evaluations)
Assess complaints for completeness and determine need for investigation or signal evaluation
Analyze complaint data to identify safety signals or adverse trend patterns for signal detection & evaluation.
Conduct statistical evaluation to determine the significance of identified signals
Draft signal evaluation reports and adverse event reports (e.g., MDRs) according to FDA, EU MDR, ISO and other global regulatory standards
Identify the risks pertaining to signals for the signals detected
Liaise with engineering, manufacturing, regulatory, clinical, and quality teams to support investigations and CAPA actions
Escalate high-risk signals for management review and regulatory notification
Ensure investigations and reports comply with 21 CFR 803/820, FDA MDR, ISO 13485, ISO 14971, EU MDR, etc.
Support audits, docu

📌 Quality Engineer II (Hyderabad)
🏢 Medtronic
📍 Hyderabad