What Quality Engineering contributes to Cardinal HealthQuality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.Job SummaryThe Senior Engineer Quality leads quality assurance processes at the assigned facility. The Sr. QA Engr, Complaints will be responsible for diligent and thorough analysis, investigation of product complaints and leads process improvement activities for complaint investigations.ResponsibilitiesPerform device analysis in accordance with model-specific procedures and protocols.Provide statistical support and analytical problem solving to identify root cause of problems.Respond to complaints and non-compliance and sign off on deviations, validation, and other design verification protocols.Conduct trending analysis with non-conformance compliance and develop month-end reports and management reviews.Develop correctional and preventative actions for quality related processes.Serve as an internal auditor and support external audits.Perform other duties in line with business needs.Qualifications2-4 years QA complaint handling experience in medical device.Bachelor's degree in related field, or equivalent work experience, preferred.Knowledge of FDA and ISO 13485 regulation and standards.Advanced fluency in English.Demonstrated ability to work effectively with cross-functional teams for complaint investigation and root cause analysis.Thorough knowledge of relevant GMPs and Good Documentation Practices.Strong analytical skills.Proficient in Microsoft Office tools such as Word, Excel, PowerPoint, Outlook.Proficiency in Minitab.Ability to thrive in a dynamic environment.What is expected of you and others at this levelApplies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks.Works on projects of moderate scope and complexity.Identifies possible solutions to a variety of technical problems and takes action to resolve.Applies judgment within defined parameters.Receives general guidance and may receive more detailed instruction on new projects.Work reviewed for sound reasoning and accuracy.#J-18808-Ljbffr