JOB REQUIREMENTS: Resuscitation, ZOLLMED.com At ZOLL, we\'re passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people\'s lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Circulation division of ZOLL Medical Corporation is focused on \"beating heart\" therapies for hospitals. Post-cardiac arrest, STEMI heart attack, and severe fever are some of the applications of ZOLL\'s unique devices. Fully integrated, ZOLL Circulation researches, develops, manufactures, and sells novel technologies includes ZOLL Temperature Management Solutions and TherOx SSO2 Therapy. Temperature Management Solutions empower physicians to \"prescribe\" a temperature and achieve it. TherOx SSO2 Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks. Job Summary The Principal Quality Assurance Compliance Engineer ensures all Corrective Action/Preventive Action (CAPA) and Internal Audit activities comply with ZOLL\'s Quality Management System (QMS). This individual will be responsible for identifying, analyzing, investigating, monitoring, and documenting patterns and trends in post-market surveillance data as part of the CAPA and Internal Audit systems, as well as communicating to Management, QA, R&D, Operations, and other departments regarding product performance, quality compliance, and system metrics. In addition, the Principal Quality Assurance Compliance Engineer will also be responsible for leading and coordinating all External Auditing, Quarterly Management Review, New Employee Training, and QMS Continuous Process Improvement activities. Essential Functions Ensure all CAPA records are established, maintained, documented, and closed promptly and according to QMS procedures. Assist CAPA owners with investigations, action plans, and verification and validation activities. Assist owners in root cause analysis. Chair the monthly CAPA management meeting and provides metrics for CAPA status. Gather and analyze metrics to measure effectiveness and makes recommendations to improve the CAPA program. Coordinate the review of CAPAs to determine their effectiveness. Ensure on-time completion of CAPAs. Identify and execute opportunities for continuous improvement (Lean). Interface with FDA and third-party auditors during inspections. Oversee the internal audit program and the audit program\'s corrective actions. Ensure that all corrective actions from internal and external audits are practical and verified. Act as liaison with regulatory agencies to obtain information related to product standards and regulations. Lead quality system audits to ensure the QMS operates in a state of compliance and continuous... For full info follow application link. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/7EBDDF56AC394650