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Senior Quality Engineer

1 month ago

Cincinnati, United States AtriCure Full time

Senior Quality Engineer Cincinnati, OH, USA * Dayton, OH, USA * Mason, OH, USA Req #2152 Tuesday, July 9, 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. This position will be onsite in our Mason, OH Headquarters. Must be able to relocate or commute to this location. POSITION SUMMARY: This position will work closely with AtriCure engineering, manufacturing and suppliers to ensure that quality system activities are completed. The Senior Quality Engineer is responsible for the development and implementation of company-wide quality systems including: Compliance with global regulatory requirements Development to support new product development activities Ensuring that the quality management system focuses on continuous improvement ESSENTIAL FUNCTIONS OF THE POSITION: Develop and implement quality systems and establish procedures in compliance to global regulatory requirements (e.g. FDA, EU MDD, CMDR, ISO, etc.) Direct and support Suppliers, Engineering, Inspection, Calibration, Internal Auditing, CAPA, Quality Engineering and Document Control Represents Quality for projects including new products and existing product improvement. Supports protocol, procedure, design controls and specification development Work closely with Quality Management and other departments in developing and executing company strategies Work closely with the quality management and other departments in developing documentation to support technical design reviews. Negotiation and problem-solving skills Assist with FDA and ISO audits. Perform internal and supplier audits as necessary Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts Generally, operates with appreciable latitude for actions and/or decisions on day-to-day activities with minimal guidance from management. ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: Regular and predictable work performance Ability to work under fast-paced conditions Ability to make decisions and use good judgment Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assigned BASIC QUALIFICATIONS: Bachelor's degree in engineering required or demonstrated equivalent combination of education, training and experience. Five years Engineering experience FDA and ISO 13485 knowledge Problem Solving/Troubleshooting experience Auditing experience (Financial/Quality) Experience with reading technical specifications Inspection/testing experience Data analysis experience Computer/data entry skills Written/report wri