Job SummaryThe Principal Design Quality Engineer is responsible for leading and managing quality assurance of medical device products and processes. This role will lead quality and compliance activities for Cardinal Health which includes diverse medical devices. Principal Design Quality Engineer/Principal Quality Engineer ensure that product quality and regulatory compliance goals are met for new product development projects and released products.ResponsibilitiesApplies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.Ensure that products compliance to ISO 13485 and 21 CFR 820 Quality system regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.Involve in continuous improvement activities.Identifies and implements data analysis, system conformance and ensure finished goods meet standards and specifications, implement and drive changes where needed.Support Regulatory, Medical Affairs, Research and development, Manufacturing, Supplier, Audit, CAPA and Program Management team, as required.Perform activities related to Risk Management Plan, Hazard Identification Worksheet, Risk Analysis Chart, and Risk Management ReportMay contribute to the development of policies and procedures.Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives.Complete task independently after receiving general guidance on new projects.Qualifications4-8 years of experience, preferred.BA, BS or equivalent experience in related field. Advance Degree, preferred.What is expected of you and others at this levelApplies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.May contribute to the development of policies and procedures.Works on complex projects of large scopeDevelops technical solutions to a wide range of difficult problems.Solutions are innovative and consistent with organization objectives.Completes work; independently receives general guidance on new projects.Work reviewed for purpose of meeting objectives.May act as a mentor to less experienced colleaguesCandidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
