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 As a Quality Engineer, you will be responsible for process validation and will work closely with the engineering and manufacturing teams. You'll collaborate with the Validation Team to prepare CSV documents and execute test protocols. You'll also contribute to projects aimed at upgrading production equipment to ensure quality standards are upheld. You'll be part of the Quality Assurance group within the Validation Team and report directly to the Quality Assurance Manager. The role is based in Mirandola, working in close contact with the manufacturing department. Responsibilities may include the following and other duties may be assigned: Develop, modify, and maintain quality standards and protocols for processing materials into partially finished or finished products. Partner with engineering and manufacturing teams to ensure quality standards are met. Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Conduct statistical analysis to assess performance and perform visual inspections to ensure products meet established standards and specifications. Ensure corrective actions meet reliability standards and maintain compliance with documentation requirements. Work with the validation team to execute and monitor process and product validations. Prepare CSV documents and carry out test protocols. Develop Process Risk Analysis and Process Mapping. Contribute to projects focused on production equipment upgrades. Required Knowledge and Experience: Degree in a scientific discipline Proficiency in Microsoft Office Programs Strong communication skills in English, both written and spoken Knowledge of statistical tools, process validation, and test methods Familiarity with Computerized System Validation (21 CFR part 11, GAMP 5) Understanding of Test Method Validation and Measurement System Analysis Ability to work effectively in a team and communicate well with production personnel Attention to detail and flexibility in managing various tasks Experience in medical device and standard measurement instruments as well as basic knowledge of technical drawing will be preferred. 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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). 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 90,000 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. J-18808-Ljbffr