Senior Quality Engineer

Cytiva

Pensacola, United States
Quality management system (qms)
Iso 13485 and iso 9001 compliance
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.
  • You will lead root cause analysis and implement CAPA for nonconformities using the risk management processes, and ensure design control process compliance throughout the product lifecycle.
  • 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 compliance
  • 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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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