AtriCure, Inc. · 16 hours ago
Staff Supplier Quality Engineer
Mason, OH
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expAtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Staff Supplier Quality Engineer will develop and implement supplier-related quality system requirements, ensuring compliance with regulations while supporting new product development and manufacturing activities with a focus on continuous improvement.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
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 judgment
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
Qualification
Required
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 communication skills. Greater use of tools above MS Office (ie. Visio, Power BI, etc) for communication and analysis
Statistical use experience – Assessing capability, running hypothesis tests
Details-oriented with demonstrated problem solving/trouble shooting experience of larger magnitude
Must be able to read technical specifications, blueprints, and drawings. Working knowledge of GD&T
Engineering/Manufacturing background – preferably machining, molding, and finishing processes
Ability to regularly walk, sit, or stand as needed
Ability to occasionally bend and push/pull as needed
Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
Ability to pass pre-employment drug screen and background check
Preferred
Advanced degree
MDD, CMDR and JPAL knowledge
ASQ Certified Quality Engineer
ASQ Certified Quality Auditor
Benefits
Medical & Dental beginning day 1 of employment
401K plus match
20 days of paid Parental Leave
Maternity leave
Volunteer Time off
Pet Insurance
Full access to our on-site fitness center and cafeteria
Company
AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide.
1001-5000 employees
H1B Sponsorship
AtriCure, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (7)
2022 (10)
2021 (5)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$201MKey Investors
U.S. Venture Partners
2020-05-12Post Ipo Equity· $175M
2005-08-05IPO
2002-06-10Series Unknown· $21M
Leadership Team
Michael H. Carrel
President and Chief Executive Officer
Tamer Ibrahim
Vice President, Research & Technology
Recent News
Company data provided by crunchbase