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