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Senior Quality Systems Specialist

Company: Hill-Rom
Location: Cary
Posted on: April 4, 2021

Job Description:

\n\n Description \n\n \n\n JOB SUMMARY: \n\n \n\nThe Senior Quality Systems Specialist will support Quality System Management functions for Hillrom Care Communications located in Cary, NC, Jupiter and Sarasota, FL. The role will have direct interaction with leaders and directors across various functions at both the local and corporate levels. The Senior Quality Systems Specialist will be responsible for managing the Corrective and Preventative Action program including nonconformance evaluations, root cause analysis, and assisting with compliance audits.\n\n \n\n ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned as needed: \n\n \n\n Primary areas of ownership, responsibility and accountability: \n\n \n\nManages the Corrective and Preventive Actions (CAPA) system to ensure regulatory compliance and effectiveness across the business through driving collaboration, direction, management, and oversight of the CAPA process\n\n \n\nManages nonconformance evaluations, assists with correction development and CAPA escalation assessment\n\n \n\nCollaborate with internal departments and CAPA owners with Root Cause Analysis, Action Plans and Effectiveness Checks\n\n \n\nChairs the site level CAPA review boards and ensures that CAPA action plans are effective and managed in a timely manner\n\n \n\nProvides training, coaching, and consultation to business partners as it relates to the CAPA and Non-conformance processes\n\n \n\nAssists with coordinating and executing the internal audit program to ensure regulatory compliance and effectiveness\n\n \n\nParticipates in notified body and regulatory audits as required assisting with audit preparation, facilitation, and audit response\n\n \n\nAssists with the application of the Hillrom supplier quality program for Care Communications to ensure the implementation and effectiveness of supplier quality development initiatives and supplier performance management\n\n \n\nProvides oversight and direction for supplier evaluations and supplier quality systems/manufacturing process audits\n\n \n\n Qualifications \n\n \n\n EDUCATION, EXPERIENCE AND QUALIFICATIONS: \n\n \n\nBachelor of Science; with 5 years of Experience in Quality Assurance desired\n\n \n\nExperience in a medical device industry and knowledge of Quality System Regulations (QSR 21CFR) required\n\n \n\nSound knowledge and exposure to Medical Device Regulations (FDA, MDD/MDR, MDSAP etc.) related ISO/IEC standards (ISO 13485, IEC 62304, ISO 14971, MDDS, TIRs etc.) desired\n\n \n\nCollaborator, Self-Starter, Quick Learner, with excellent analytical decision making and problem-solving skills\n\n \n\nExcellent written and verbal communicator & influencer with good interpersonal and the ability to build partnerships\n\n \n\nAbility to travel -10% for training, seminars, audits & inspections\n\n \n\n PHYSICAL REQUIREMENTS: \n\n \n\nNOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation\n\n \n\n Job: Quality\n\n \n\n Primary Location: United States-North Carolina-Cary\n\n \n\n Schedule Full-time\n\n \n\n Travel Yes, 10 % of the Time\n\n \n\n Posting Entity Hillrom\n\n \n\n Req ID: 21122298\n\n

Keywords: Hill-Rom, Cary , Senior Quality Systems Specialist, Other , Cary, North Carolina

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