Senior Medical Device Design QA Lead

Avanos Medical, Inc.; Alpharetta (GA); Presencial; USD 110 000 - 140 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) employer match

Benefits on day 1

Free onsite gym

Onsite cafeteria

HQ region voted 'best place to live'

Resumo da oferta

Avanos Medical, Inc. in Alpharetta, Georgia, is seeking a Senior Design Quality Assurance Engineer to lead risk management and design control activities for new product development and post-market changes.

The role drives documentation adequacy for regulatory submissions and cross-functional alignment to ISO 14971:2019. The position emphasizes technical and quality leadership, collaboration across teams, and a focus on continuous improvement throughout the development lifecycle.

Qualificações

• BS in Engineering, Science, or Statistics.
• 7+ years collective experience in product development and quality in a medical device environment.
• 3 years developing and improving product development processes.
• Position based in Alpharetta with office Tue–Thu.

Responsabilidades

• Develop/Maintain Risk Management File (RMF) ensuring compliance to ISO 14971:2019 and Avanos policies.
• Lead Design and Development Files for regulatory submissions and production transfer.
• Provide technical and quality leadership in solving complex quality issues and projects.
• Participate in development of statistical plans for design control and justify sample sizes.
• Collaborate with project teams to incorporate quality system elements, root cause analysis, CAPA, and continuous improvement.
• Support qualification of new suppliers/components and supplier monitoring.

Descrição da oferta de emprego

Avanos Medical, Inc. in Alpharetta, Georgia, is seeking a Senior Design Quality Assurance Engineer to lead risk management and design control activities for new product development and post-market changes.

The role drives documentation adequacy for regulatory submissions and cross-functional alignment to ISO 14971:2019. The position emphasizes technical and quality leadership, collaboration across teams, and a focus on continuous improvement throughout the development lifecycle.