AMVETS Jobs

Microbiologist Cincinnati, OH, USA * Mason, OH, USA Req #2040 Monday, April 15, 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 executing microbiological testing in a GMP regulated environment to support environmental monitoring and product testing requirements. Additionally, the role may support non-routine projects, validations, and method developments to meet departmental and individual goals. ESSENTIAL FUNCTIONS OF THE POSITION: Execute routine microbiological testing sampled from a classified controlled environment, including enumeration, gram stain and organism ID to support the EM program. Execute routine microbiological testing sampled from various utilities systems to support the EM program. Execute component and product testing of medical devices through execution of membrane filtration and plate count methods, endotoxin analysis, growth promotion and microbial identification. Support implementation of new instruments, equipment and methodologies as required including performing/ reviewing IQ/OQ/ PQ data for qualification. Perform data entry, laboratory reporting and record keeping following good documentation practices as required. Control handling of samples and data integrity to ensure chain of custody for all testing performed. General laboratory housekeeping duties, sample receipt, expiration and inventory checks as well as maintenance of the lab and equipment. Coordinate the compilation and reporting of results through monthly metrics, trend reports and dashboards. Analyze data and metrics and notify appropriate personnel of negative trends, alert and action level excursions. Generate non-conformance reports as necessary and support out of specification investigations. Suggest and implement procedure and process changes to align with current industry standards and practices. Support team with quality system tasks including investigations, CAPAs, etc. 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 judgement Ability to prioritize various duties and multitask as required Ability to successfully work with others Ability to work safely, seek out and encourage safe practices. Ability to learn on the job and ask effective questions. Critical thinker, ability to identify issues and work quickly to bring to resolution. Ability to suggest and support implementation of lab improvements or modify existing process to maximize quality and efficiencies in the lab. Ability to stay organized and use effective time manag