Quality Engineer II

Quality Engineer II

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

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, document reviews, and CAPA follow-through as needed
• Good verbal and written communication skills including plan / report development.

Required Knowledge and Experience

• B E or B.Tech in Mechanical/Biomedical Engineering
• Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 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.

 

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. 

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. 

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Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

 

 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Experience Level

Senior Level