Quality Engineer II

Requirements

• Medical device industry experience.
• Familiarity with these regulations: FDA 21 CFR Part 820, EU 217/745 (EU MDR).
• Familiarity with these standards: ISO 13485, ISO 14971, IEC 60601.
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• 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.
• U.S. Work Authorization & Sponsorship
• Join us in our mission to alleviate pain, restore health, and extend life-where your unique background and perspective are valued.
• 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, resou

Benefits

Additional Information

We anticipate the application window for this opening will close on - 12 Jun 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life A Day in the Life In this meaningful role as a Quality Engineer II supporting Cardiac Ablation Solutions (CAS), you will play a vital part in ensuring product quality, safety, and reliability through post‑market activities. You will perform complaint investigations, partner closely with engineering teams to identify and escalate risk file signals, and support data‑driven decisions that protect patients and clinicians. This role supports the development and continuous improvement of procedures, processes, tools, and techniques used for product analysis and returned product evaluation. You will devise and implement inspection and testing methods for returned product, support test method validation efforts, and apply appropriate statistical methodologies to assess product performance and trends. In addition, this position contributes to building organizational capability by providing training to technicians and strengthening consistent, compliant execution of quality practices-directly supporting patient safety and the CAS product lifecycle. Job Description In general, the following responsibilities apply for the Quality Engineer II role. This includes, but is not limited to the following: - Perform complaint investigations for Cardiac Ablation Solutions products - Collaborate with the engineering team to escalate risk file signals as appropriate. - Provide support with the development of procedures, processes, tools, and techniques for performing product analysis. - Devise and implement methods and procedures for inspection and testing of returned product. - Support test method validation activities. - Apply and understand statistical methodologies, as appropriate. - Provide training to technicians. Must Have - Minimum Requirements TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME - Bachelor's degree in Engineering, Science, or a related technical discipline. Minimum of 2 years of relevant experience in Engineering and or Quality, or an advanced degree in Engineering, Science, or a related technical discipline with 1+ years of relevant work experience in Engineering and or Quality.

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