Quality Engineer II

Job Description

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 Responsibilities may include the following and other duties may be assigned: Analyze returned products to identify failure modes and root causes. Conduct detailed assessments of device performance, including physical inspection and functional testing. Document investigation findings in the complaint handling system, ensuring accuracy and completeness. Review complaint data for trends and recurring issues. Identify opportunities for streamlining failure analysis workflows to improve efficiency and accuracy. Contribute to the development and implementation of standardized investigation procedures and tools. Support automation initiatives to reduce manual effort in complaint handling Ensure all complaint investigations comply with regulatory requirements (e.g., MDR, FDA). Maintain detailed and accurate records for audits and inspections. Support internal and external audits by providing investigation data and process documentation. Serve as a subject matter expert (SME) for failure analysis techniques and tools. Stay updated on industry standards and best practices for complaint handling and failure analysis. Train and mentor junior team members in complaint investigation and analysis methods. Monitor and report on key performance indicators (KPIs) related to complaint handling (e.g., FTQ, OCT). Drive improvements to meet or exceed quality and timeliness targets. Required knowledge, experience & skills : Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 4 to 8 years of quality systems experience. Strong communication skills, both oral and written. Ability to understand the functionality / intended use of complex medical devices Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis Comfortable working with international and multi-cultural department and groups in different time zones Accurate and delivers quality work, with a sense of urgency. Ability to work well under pressure and maintain positive, enthusiastic attitude. Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities & accountability . Skills - Nice to have : Knowledge of medical devices, their development and quality control. Knowledge of FDA, MEDDEV, Canadian Regulations. Technical Writing experience. Good interpersonal skills. Ability to work effectively in a team environment and build strong working relationships. 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. 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. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here