AtriCure

AtriCure

Senior Supplier Quality Engineer

United States of America · Senior · Contract

Sponsorship not specifiedDetected 8 hours ago
Data AnalysisFDA RegulatoryMedical DevicesCommunicationProblem Solving

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Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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About the role

  • QMS qualification and monitoring including supplier audits and assessments
  • Correction activities including managing NCRs and SCARs.
  • Supplier change requests and improvement

Responsibilities

  • Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metrics
  • Able to support both New Product Development activities at suppliers as well as sustaining activities for existing components and subassemblies.

Requirements

  • 4+ years of experience
  • Experience with inspection/testing and data analysis
  • Must be able to read technical specifications, blueprints, and drawings
  • Ability to travel 25%

Nice to have

  • MDD, CMDR and JPAL knowledge
  • ASQ Certified Quality Engineer
  • Statistical use experience
  • Experience with Metal Injection Molding (MIM) suppliers
  • 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

Skills

  • AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions.
  • Afib affects more than 33 million people worldwide.
  • 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.
  • For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

Benefits

  • https://www.atricure.com/careers-atricure/benefits.

Company info

  • We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
  • Work closely with Quality Management, Product Development, and other departments in developing and executing company strategies

This listing is sourced directly from AtriCure's careers page and normalized into a canonical job model.