Sr. Quality Engineer - New Product Development

BD

Covington, GA, USA
Not specified; not specified; not specified
Fully remote
Bs degree in engineering or science
3 years quality design engineering experience
5 years fda regulated environment experience
This role serves as the dedicated Quality Representative on cross-functional project teams to ensure Design Control principles are applied to new product development

Job Summary

  • This role serves as the dedicated Quality Representative on cross-functional project teams to ensure Design Control principles are applied to new product development.
  • The position requires developing sophisticated Risk Assessments including FMEA, FMECA, and FTA to proactively identify and mitigate potential issues.
  • BD prioritizes on-site collaboration with a minimum requirement of 4 days per week in the office to foster creativity and innovation.

Matching Summary

This role serves as the dedicated Quality Representative on cross-functional project teams to ensure Design Control principles are applied to new product development.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • BS Degree in Engineering or Science
  • 3 years Quality Design Engineering experience
  • 5 years FDA regulated environment experience
  • Design Control principles application
  • FMEA, FMECA, and FTA risk assessments
  • CAPA and Audit documentation expertise

Nice-to-have

  • Capital system electro-mechanical experience
  • ASQ Certification preferred
  • International supplier collaboration history
  • Mentorship and team leadership skills
  • Active trade organization participation

Key Requirements

  • BS Degree in Engineering, Science or Technical Field
  • 3 years Quality Design Engineering experience
  • 5 years FDA regulated environment experience
  • ASQ Certification (Preferred)
  • US work authorization required for Georgia location

Work Rights

Not specified

Tailored Resume

Cover Letter