Staff Engineer - Quality Document Systems

BD

Durham, NC, USA
Remote
10 years qms administration experience
8 years medical device industry experience
Document control and change management expertise
BD is seeking a Staff Engineer for Quality Document Systems, responsible for overseeing and improving the Quality Management System (QMS) to ensure compliance and enhance quality processes. The ideal candidate will have extensive experience in QMS administration and is expected to collaborate across departments to elevate compliance standards

Job Summary

  • This role serves as a key member of the Quality organization responsible for technical oversight and continuous improvement of document and change management processes within the Quality Management System.
  • The position requires managing both internal and external audits while developing strategic corrective action plans to address root causes of issues in compliance procedures.
  • Candidates must possess at least 10 years of experience with emphasis on QMS administration and 8 years specifically in the medical device or life science industry.

Matching Summary

Match Score: 85

BD is seeking a Staff Engineer for Quality Document Systems, responsible for overseeing and improving the Quality Management System (QMS) to ensure compliance and enhance quality processes. The ideal candidate will have extensive experience in QMS administration and is expected to collaborate across departments to elevate compliance standards.

Skills & Requirements

Must-have

  • 10 years QMS administration experience
  • 8 years medical device industry experience
  • Document control and change management expertise
  • Audit management and CAPA implementation
  • Electronic documentation system administration

Nice-to-have

  • Learning Management System (LMS) coordination
  • Pharmacy Automation training curriculum design
  • Cross-functional collaboration skills
  • Strategic corrective action planning
  • Data-driven quality improvement initiatives

Key Requirements

  • Bachelor's degree in engineering, life sciences, or related field
  • Minimum 10 years of QMS and audit management experience
  • At least 8 years of medical device or life science industry experience

Work Rights

Not specified

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