Careers that Change LivesWe're a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.Come strengthen your specialized skills and enhance your expertise. We'll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that's best for you. Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.A Day in the Life·Serves as the quality expert for assigned programs and is responsible for making strategic quality decisions throughout the product lifecycle. Provides a proactive front-end approach to product quality. Ensures deliverables are aligned to process.·Delivers strong written and verbal communication skills with ability to communicate effectively to a wide audience, including subordinates, peers, and superiors, and requires minimal supervision.·Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.·Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.·Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.·Provides oversight for the development and maintenance of quality programs, systems, and processes that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.·Lead and influence Quality System procedures and process improvements including developing and updating and owning procedures.·In collaboration with operations, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes.·Trains and mentors other Quality department staff to perform quality duties.Must Haves·7+ years of experience with a bachelor's degree or 5+ years of experience with an advanced degree·Non-product software including 21 CFR Part 11 and/or healthcare validation delivery experience·Proficiency in Microsoft Tools including Word, Excel, Teams, SharePoint·Proficiency in multitasking and time management·Experience with validation of various system hosting configurations (cloud, on-prem)·Proficiency with data migration activitiesNice to Haves·Previous Medtronic experience·Has a history of completing successful projects and driving positive compliance outcomes·Solid working knowledge of FDA 21 CFR Part 11, 21 CFR Part 820, QSR/ ISO 13485 regulations and standards·History of driving results with a sense of urgency, good communications skills, and ability to manage details.·Ability to learn quickly and prioritize tasks in a fast paced and dynamic environment·Experience shifting CSV to CSA implementationOur CommitmentOur unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world. About MedtronicBold thinking. Bolder actions. We are 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. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world.In everything we do, we areengineering the extraordinary.Your AnswerIs this the position you were waiting for? Then please apply directly via the apply button!#LI-Remote
