Jobs for People with MS: National MS Society

Quality Systems Engineer Cincinnati, OH, USA * Mason, OH, USA Req #2043 Thursday, May 23, 2024 AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. POSITION SUMMARY: This position will be responsible for the development support and implementation of company-wide quality systems including compliance with international and national regulations regarding software validation and support of other Quality System processes. ESSENTIAL FUNCTIONS OF THE POSITION: Focus on supporting the implementation and continuous improvement within the Quality System around software validation and the governing procedures. Focus on supporting the quality management system including investigations, CAPA's, procedure development and maintenance, and quality metrics. Support and maintenance of established procedures in compliance with FDA regulations, ISO requirements, GAMP5 and other applicable global regulations and standards. Direct and support Information Systems/Information technology, Engineering, CAPA, Quality Engineering, and Document Control as necessary Represent Quality for projects that may include product, process, or Quality System improvements. Support protocols, procedures, design controls, specification development, etc. as needed May own and manage CAPA and/or Investigation system(s) for the associated software; provide guidance, training, and assistance Support Quality Systems (e.g. Procedure Development/Maintenance, Corrective and Preventive Actions, Investigations, etc.) and Domestic/International Regulatory Compliance Activities Work closely with Quality Management and other departments in developing and executing company strategies Assist and support FDA, BSI, and other external audits as needed Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts. Evaluates information and procedures to propose an appropriate course of action Own and lead projects with guidance; provide updates and/or work for manager to review Compile and present information/updates to the organization and leadership as needed Familiar with domestic and international standards and controls which are job related such as Risk Management, Software systems, Requirement cascades, Good Documentation Practices, or other Operates with appreciable latitude for actions and/or decisions on day-to-day activities. Receives or seeks guidance on novel or controversial problems that may impact the business significantly Perform other duties and projects in addition to the above as necessary ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable worksite attendance Strong org