AtriCure Principal Supplier Quality Engineer in Cincinnati, Ohio

Principal Supplier Quality Engineer

Location:Cincinnati, OH

Department:Quality Systems

Employment Duration:Full Time Regular

FLSA Status:Exempt

Description

AtriCure, Inc.is a medical device company that provides innovative solutions designed to decrease the global Afib epidemic. AtriCure’s Isolator® Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip® Left Atrial Appendage Management (LAAM) exclusion device is the most widely sold device worldwide that is indicated for the occlusion of the left atrial appendage. AtriCure believes electrophysiologists and cardiothoracic surgeons are adopting its technologies for the treatment of Afib and reduction of Afib related complications. Afib affects more than 33 million people worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

Position Summary:

The Principal Supplier Quality Engineer is responsible for the development, implementation, and management 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.

ROLES AND RESPONSIBILITIES:

  • Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, ISO requirements, Medical Device Regulation (MDR), Canadian Medical Device Regulations (CMDR), and other global regulatory requirements including evaluations, audits, and metrics

  • Lead supplier-related inspection and monitoring activities including control plans, (supplier) corrective actions (SCARs), supplier change requests (SCRs), scorecards, the Approved Supplier List (ASL), and other quality engineering projects as needed

  • As a member of the Quality team, work with other departments in developing and executing company strategies and quality objectives

  • Able to work cross-functionally, overcome challenges, and facilitate cooperation with suppliers to meet global regulatory requirements

  • Responsible for the management and execution of the supplier audit schedule including performing actual audits

  • Assist with FDA, ISO, and other global audits as needed

  • 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, actions and/or decisions on day-to-day activities.

  • Determines appropriate response to novel or controversial problems that may impact the business significantly

  • Other duties as necessary and assigned

BASIC QUALIFICATIONS:

  • Bachelor’s degree in engineering or equivalent

  • CQE certification

  • CIA certification

  • FDA and ISO 13485 knowledge and audit experience

  • At least 7 years in supplier quality engineering/leadership

  • Willingness to travel, extensively as needed

  • Experience with inspection/testing and data analysis

  • Strong computer/data entry, planning, report writing, and communication skills

  • Detail-oriented with strong problem solving/troubleshooting experience

  • Must be able to read technical specifications, blue prints, and drawings

PREFERRED QUALIFICATIONS:

  • Medical device experience strongly preferred

  • MDD/ MDR, CMDR and JPAL knowledge

  • ASQ Certified Quality Engineer

  • ASQ Certified Quality Auditor

  • Strong Statistical applications background

  • Eng./Design background

ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement – i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %; O=Occasional, R=Regularly, N=Never):

  • Regularly walk, sit, and stand

  • Occasionally bend and push/pull

  • Regularly lift up to 25 pounds, occasionally lift over 25 pounds

  • 30%+ travel possible

  • Position dependent upon candidate passing pre-employment physical/drug screen

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.