Sr. Quality Engineer

81

Santo Domingo, Dominican Republic
Quality management systems (qms)
Fda regulations
Device history records (dhr)
The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields to ensure customer expectations are met or exceeded

Job Summary

  • The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields to ensure customer expectations are met or exceeded.
  • You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • You will lead plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.

Matching Summary

The primary purpose of this job is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields to ensure customer expectations are met or exceeded.

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • Process validation
  • Statistical Quality Control
  • Root cause analysis

Nice-to-have

  • Collaborate with cross-functional teams
  • Positive, can-do attitude
  • Calm demeanor in high-energy environment
  • Subject matter expert
  • Continuous improvement suggestions

Key Requirements

  • Bachelor's degree in engineering or related field
  • 7+ years of progressive engineering experience
  • 6-Sigma Green Belt minimum
  • Awareness of Domestic and International Regulations

Work Rights

Not specified

Tailored Resume

Cover Letter