Manager, Quality Engineering

4 weeks ago


Cincinnati, United States AtriCure Full time

Manager, Quality Engineering Cincinnati, OH, USA * Dayton, OH, USA * Mason, OH, USA Req #1978 Tuesday, March 12, 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. Onsite position. Must be able to relocate to the Cincinnati area. POSITION SUMMARY: This position will be responsible for management of the quality engineering group and processes that affect technical product quality and impact the state and control of finished product in compliance with global regulatory requirements (ISO, FDA, MDD, MDR, etc.). The Manager, Quality Engineering is responsible for ensuring production and process controls are consistently within a state of control ensuring effective risk mitigations are put in place. Responsibilities include setting direction, planning, coordination, and timely completion of day-to-day activities. The primary activities will be in support of internal manufacturing quality which includes selection of inspection and verification methods, process validation, product non-conformances, investigations, and corrective actions. Secondary activities will be in support of supplier quality, product development, sustaining engineering, regulatory affairs, and manufacturing engineering. ESSENTIAL FUNCTIONS OF THE POSITION: Manage Operations activities by providing quality leadership and direction to quality engineering team to ensure company objectives are met in a timely manner. Manage the tactical execution of short- and long-term quality engineering and production and process control objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing. Coordinates and manages the efforts of multiple staff levels and disciplines/specialties within quality engineering. Leads and models the need for interpersonal and cross functional coordination, and initiates company-wide cooperative actions to ensure effectiveness of quality engineering and production and process controls. Provides oversight responsibility for the NCR system within area of responsibility, including managing day to day execution of the process as well as the review and improvement of the NCR process itself. Provide leadership, mentoring, and development plans for all direct reports to maintain an engaged and productive workforce. Manages and mentors employees in department to ensure initiatives and objectives are obtained; seeks feedback to identify improvement activities and acknowledges others efforts and accomplishments. Technically proficient in quality engineering. Utilizes proven techniques and knowledge of functional area to significantly contribute at the individual contributor and manager level. Works on issues of diverse s


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