Quality Assurance Engineer

CMS The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies. 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. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives. 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 purpose Performs a variety of complex tasks related to Quality Assurance including, but not limited to: 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. Duties and responsibilities Performs internal quality audits and effectiveness reviews (FDA’s QSR, ISO 13485, MDD, CMDR). Conducts supplier evaluations and audits. Responsible for the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality. 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. Responsible to build and improve key business relationships within the organization’s cross functional departments. 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. Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented. Conducts various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses. Prepare, submit and coordinate the process validation requirements for non-product software validations. 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. Performs other duties as assigned by Management. Qualifications Requires a BS degree or equivalent experience in a technical or scientific discipline. Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred. Experienced in process development and validation for electro-mechanical assembly, test, and service. Formal Project management experience a plus. Six Sigma Green Belt or Black Belt preferred. Understands and has applied in practice the concepts of process capability, process control, and measurement system capability. Lean experience preferred. Experience with database queries and reporting in SQL or Microsoft Access preferred. 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. Physical requirements 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; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Supervisory responsibility None AAP/EEO Statement ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued. Equal Opportunity Employer – Disability and Veteran LI-KH1 Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification. ZOLL Medical Corporation appreciates and values diversity. We are an Equal Opportunity Employer M/F/D/V. 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 www.zoll.com. 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 www.asahi-kasei.co.jp/asahi/en/.