Senior Quality Engineer

Cytiva

Pensacola, United States
Quality management system (qms)
Iso 13485 and iso 9001
Root cause analysis and capa
The Senior Quality Engineer is responsible for ensuring the quality of membrane products and medical devices by facilitating cross-functional execution of the Quality Management System (QMS), setting inspection processes, implementing quality control measures, and identifying statistical trends

Job Summary

  • The Senior Quality Engineer is responsible for ensuring the quality of membrane products and medical devices by facilitating cross-functional execution of the Quality Management System (QMS), setting inspection processes, implementing quality control measures, and identifying statistical trends.
  • This role ensures compliance with ISO 13485, and ISO 9001 standards, addresses customer complaints, resolves production quality issues, and supports new product introduction projects.
  • Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.

Matching Summary

The Senior Quality Engineer is responsible for ensuring the quality of membrane products and medical devices by facilitating cross-functional execution of the Quality Management System (QMS), setting inspection processes, implementing quality control measures, and identifying statistical trends.

Skills & Requirements

Must-have

  • Quality Management System (QMS)
  • ISO 13485 and ISO 9001
  • Root cause analysis and CAPA
  • Design control process compliance
  • Lean/Six Sigma methodologies

Nice-to-have

  • Culture of belonging
  • Continuous improvement mindset
  • Cross-functional collaboration
  • Innovation for tangible impact

Key Requirements

  • Bachelor’s degree in Engineering or Science
  • 7+ years medical device quality engineering
  • Strong knowledge of ISO 13485, FDA QSR, ISO 9001
  • Risk management tools expertise

Work Rights

Not specified

Tailored Resume

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