Sr Quality Engineer (endourology)

BD

Covington, GA, United States
Fully remote
Design control principles
Product/process changes
New product development
Serve as the dedicated Quality Representative on cross-functional project teams, ensuring Design Control principles are meticulously applied to all Product/Process Changes and New Product Development initiatives

Job Summary

  • Serve as the dedicated Quality Representative on cross-functional project teams, ensuring Design Control principles are meticulously applied to all Product/Process Changes and New Product Development initiatives.
  • Craft, review, and approve detailed Product Documents including Design History Files that tell the complete story of our products.
  • At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.

Matching Summary

Serve as the dedicated Quality Representative on cross-functional project teams, ensuring Design Control principles are meticulously applied to all Product/Process Changes and New Product Development initiatives.

Skills & Requirements

Must-have

  • Design Control principles
  • Product/Process Changes
  • New Product Development
  • Quality System Documents
  • CAPA and Audits
  • Design History Files
  • Process and Product Validations
  • Risk Assessments
  • Software validation protocols
  • Internal and Supplier Audits
  • Product complaints investigation

Nice-to-have

  • Cross-functional collaboration
  • Mentorship and staff development
  • Industry professional engagement
  • On-site collaboration culture
  • Work-life balance focus

Key Requirements

  • BS Degree in Engineering, Science or Technical Field
  • 3 years of Quality Design Engineering experience
  • 5 years of experience in FDA regulated environment
  • Capital system experience (Electro-mechanical)
  • ASQ Certification

Work Rights

Not specified

Tailored Resume

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