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Technical Quality Engineer (3969)

Company: Avanos Medical
Location: Alpharetta
Posted on: June 23, 2022

Job Description:

The roleThe major purpose of this position is to Lead the on-going activities required to support the assigned product category activities.These activities include, but are not limited to: Support design changes, product enhancements, material changes, and process changes; investigation of product non-conformances; communication with customers, ensure compliance to quality system requirements; support Avanos operated manufacturing facilities and supply base; support acquisitions and integrations.Essential Duties and Responsibilities:

  • Actively participates in and/or facilitate the development of deliverables required to qualify product changes ensuring that customer requirements and specifications are met
  • Maintains the Risk Management files which includes Hazards Analysis, Design FMEA, Use FMEA & Process FMEA for assigned product families
  • Solves challenging technical problems, provides expertise in related specific field of knowledge and consults on complex issues and projects
  • Works within cross-functional teams to lead investigation of customer product complaints
  • Utilizes Root Cause Analysis concepts to investigate issues and implement Corrective and Preventive Actions including effectiveness checks
  • Ensures timely closure of active complaints providing tracking and trending data
  • Leads Global Post Market Surveillance analysis, trending, and reporting
  • Participate in internal and external audits
  • Participate in and lead due diligence and integration activities as needed
  • Partners with vendors to facilitate the completion of Supplier Corrective Actions and to build quality relationships
  • Develops, initiates, and implements new quality concepts, tools and strategies to improve business practices
  • Assists with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert
  • Assist in development of Technical Documentation
  • Conducts self in accordance with the expected Avanos values and behaviorsYour qualificationsRequired:
    • B.S. in Engineering, Science or Statistics
    • A minimum of 3 years of collective experience in medical device product development, quality assurance or manufacturing
    • Process and Test Method validation experience
    • Experience in Risk Management (ISO 14971)
    • Experience in Quality Systems (ISO 13485)
    • Proficient with Microsoft Office Programs
    • Strong Technical Writing
    • Ability to travel up to 20%, some internationalPreferred:
      • Strong understanding of statistical concepts
      • Strong understanding of design and development
      • Understanding of Six Sigma/ Lean Manufacturing statistical concepts

Keywords: Avanos Medical, Alpharetta , Technical Quality Engineer (3969), IT / Software / Systems , Alpharetta, Georgia

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