Senior Quality Assurance Engineer

In-Office Pittsburgh, PA Full time

R20219

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 SummaryThis 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 validation for electro-mechanical assembly, test, and service required. Formal Project management experience preferred. Lean experience required. Lean Six Sigma Black Belt preferred Knowledge, Skills and Abilities Understands and has applied in practice the concepts of process capability, process control, and measurement system capability. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. Working Conditions The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives. The annual salary for this position is: $96,000.00 to $130,000.00 Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at . Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit ZOLL Medical