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Senior Quality Engineer

1 month ago

Norfolk, United States Cardinal Health Full time

What Quality Engineering contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Responsibilities: Responsible for seeing that all tasks are performed in a manner that complies with site and corporate QMS. Support Quality Assurance System Manage/support internal audit program including conducting quality audits. Develop subsequent corrective/preventive actions for internal audits. Conduct QA system training. Conduct month-end trend and report metrics, weekly, quarterly in Management Review. Manage databases for compiling and reporting metrics Create and present Quality Alerts for manufacturing awareness, reinforcement of Quality requirements. Manage/Support CAPA program, determine root cause and/or preventative actions, and follow up on CAPA actions and due dates. Mentor CAPA champion and team members. Monitor/support supplier performance. Manage/support SCAR program, initiate SCARs, and track SCAR corrective actions and due dates. Perform supplier audits and initiate/monitor follow-up actions as required. Perform/support customer complaint investigations for the area of responsibility. Determine root cause/corrective and/or preventive action for customer complaints and externally generated customer SCARs. Manage/support nonconformance program for the area of responsibility. Facilitate and approve root cause/corrective and/or preventive actions for nonconforming material and/or material on hold. Facilitate MRB and recommend the disposition of nonconforming product. Manage and/or participate in quality improvement projects including collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs. Support cost savings projects. Use statistical tools to perform analysis and data trending. Perform process risk assessment and failure mode effects analysis (PFMEA). Develop specifications and test methods to meet customer, product, and internal quality requirements. This may include writing procedures to carry out requirements. Review new and modified product designs and processes for quality compliance. Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer, and internal audits as required. Represent the Quality function on new product development/process transfer projects. Provide quality engineering support for new product development. Lead and participate in production floor support/continuous improvement initiatives. QA Improvement Training (SPC, Five-Why, FDA, etc.). Maintain and evaluate sampling plans. Update/revise product control plans, inspection and test standards, and other site documentation where necessary. Document Change Request (DCR) reviews and approvals. Monitor and maintain facility Sterilization (pre and post-sterilization procedures)/Environmental Monitoring - if applicable. Monitor bioburden and dose audits for sterile product. Receive general guidance and may receive more detailed instruction on new projects. Performs other job duties as assigned. Qualifications: Bachelor's degree in a related field, or equivalent work experience, preferred 2+ years' experience in a related field preferred Understanding of FDA regulations surrounding the manufacturing of medical devices, GMPs, and process validations would be an asset Able to apply working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks Experience working on projects of moderate scope and complexity Ability to identify possible solutions to a variety of technical problems and take actions to resolve Able to exercise sound judgment within defined parameters Strong PC skills and knowledge of MS Office preferred #J-18808-Ljbffr