Senior Quality Engineer
Cincinnati, OH, USA * Dayton, OH, USA * Mason, OH, USA
Req #2049
Tuesday, April 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.
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/repor