CMS 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.
ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world:
LifeVest , the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death.
HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent.
TherOx Super Saturated Oxygen (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.
Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.
ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career.
Job Summary
This senior-level position will lead a variety of complex tasks related to Quality Assurance including, but not limited to: CAPA quality system management, internal auditing quality system management, and performing trend analyses on quality data to provide early warning of potential problems, and improvement opportunities. Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities including non-product software.
Essential Functions
Champions the internal audit quality process and effectiveness reviews ensuring cross functional compliance to our quality system manual, internal processes, and regulated bodies. (FDA’s QSR, ISO 13485, MDD, CMDR).
Lead the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality.
Champions the CAPA System process ensuring cross functional compliance to our quality system manual and internal processes.
Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ensure compliance.
Lead and improve key business relationships within the organization’s cross functional departments as a quality assurance subject matter expert.
Ensure operations quality measurement systems are capable (Gauge R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications.
Leads various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
Lead the non-product software validation process by providing project management, preparing, and coordinating the process validation requirements.
Participates in the FDA premarket approval process (PMA) for new and modified medical devices.
Participates in the nonconforming material/Material Review Board process.
Championing the implementation of Lean Manufacturing processes.
Participate in Kaizen events as a representative of the quality department.
Required/Preferred Education and Experience
Bachelor's Degree or equivalent experience in a technical or scientific discipline required.
Minimum of 5 years of Experience in an FDA regulated medical device manufacturing environment required.
Minimum of 5 years of experience in process development and…