Senior Design Quality Assurance & Risk Engineer

Avanos Medical; Atlanta (GA); Presencial; USD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits on day 1

Onsite gym

HQ region recognized

Descripción de la vacante

Avanos Medical in Alpharetta, GA, seeks a Senior Design Quality Assurance Engineer to lead Risk Management and Design Control for new product development and post-market design changes. The role emphasizes regulatory compliance, cross-functional leadership, and robust quality systems throughout the development lifecycle.

You will guide risk analyses, validation activities, and continuous improvement initiatives while partnering with project teams to ensure regulatory readiness and effective

Formación

• B.S. in Engineering, Science or Statistics is required.
• Minimum 7 years of experience in product development and quality in a medical device environment.
• Minimum 3 years developing and improving product development processes.
• Position will be based in Alpharetta, GA and work in the office Tuesday–Thursday.

Responsabilidades

• Develop/Maintain the Risk Management File (RMF) ensuring ISO 14971:2019 alignment.
• Lead Design and Development Files for regulatory submissions and production transfer.
• Provide technical and quality leadership to solve complex quality issues and advise on projects.
• Lead investigations and drive corrective actions across the lifecycle.
• Support supplier qualification and component qualifications with proper documentation.

Conocimientos

Risk Management

Design Control

ISO 14971 Compliance

FMEA

Root Cause Analysis

Regulatory Submissions

Quality Leadership

Educación

B.S in Engineering, Science or Statistics

Descripción del empleo

Avanos Medical in Alpharetta, GA, seeks a Senior Design Quality Assurance Engineer to lead Risk Management and Design Control for new product development and post-market design changes. The role emphasizes regulatory compliance, cross-functional leadership, and robust quality systems throughout the development lifecycle.

You will guide risk analyses, validation activities, and continuous improvement initiatives while partnering with project teams to ensure regulatory readiness and effective