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