Senior Quality Engineer

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 LifeAs 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 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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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).