Supplier Quality Engineer

Overview

Atri Cure, 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 Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure's cryo

ICE cryo

SPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit  or follow us on Twitter @Atri Cure.

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.

Location: This Position is located in Mason/Cincinnati, OH and will be onsite. Must be able to commute daily or relocate to Cincinnati, OH to be considered. Relocation assistance is available.

This position will be responsible for the development and implementation of supplier-related quality system requirements including compliance with international and domestic regulations in support of new product development, manufacturing, and quality management system activities with a focus on continuous improvement.

• Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metrics
• Direct and support supplier-related activities, including: QMS qualification and monitoring leading supplier audits/assessments while training other auditors
• Composes and drives timely completion of component (and sub-assembly) qualification elements such as defining requirements and assessing First Articles, Measurement Systems, equipment and process qualifications, Control Plans, etc.
• Correction activities including managing NCRs and SCARs, possibly including supplier education in these activities
• Manage and lead Supplier change requests and improvement
• Work closely with Quality Management and other departments in developing and executing company strategies – including possible leading of small group efforts
• Work cross-functionally, overcome technical and logistical challenges, and facilitate cooperation with suppliers to meet regulatory requirements
• Assist with FDA and ISO audits
• As necessary, perform internal and supplier audits as Audit Lead
• Strong working knowledge of domestic and international standards and controls relevant to the duties and expectations of this position
• Operates with appreciable latitude for, and assumes ownership of, and driving completion of actions and/or decisions on day-to-day activities
• Determines appropriate response to novel or controversial problems that may impact the business significantly and presents plans to resolve such problems
• Uses knowledge of best practices, technical proficiency, and past experiences in supplier quality engineering to mentor junior SQE's
• Other duties as necessary and assigned

• 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
• Additional duties as assigned

• Bachelor's degree with 6+ years of experience in Quality Engineering (at least 3 in Supplier Quality)
• FDA and ISO 13485 knowledge and multiple audit experiences
• Willingness to travel (~25%)
• Demonstrated experience with inspection/testing and data analysis
• Strong computer/data entry, report writing, and…