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Senior Quality Systems Engineer

$85,000–$161,500 year

On-site · Arden Hills, Minnesota, United States

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Enterprise

Job Summary

Senior Quality Systems Engineer who owns CAPA activities within field action and quality systemsProcesses to drive continuous improvement. Lead end-to-end CAPAs from planning through execution and delivery, collaborating cross-functionally with subject matter experts to identify root causes and implement effective solutions. Roles focuses on regulated environments and continuous improvement, supporting site CAPA/NCEP activities as SME, mentoring, tracking CAPA/NCEP information, and leading improvements within Arden Hills Quality Operations and related processes. Requires ability to work in a matrix organization, coordinate across teams, and manage multiple quality system initiatives; priority is strengthening CAPA ownership and overall quality system performance, with emphasis on CAPA, NCEP, and quality requirements across global teams.

Required Qualifications

  • Bachelor's degree
  • Minimum of 5 years of related experience in quality engineering or quality systems engineering within a regulated industry
  • Demonstrated CAPA and Nonconforming Product (NCP) experience
  • Proven ability to own and drive CAPAs end-to-end (planning, execution, and delivery)
  • Strong problem-solving skills with the ability to identify root cause and implement solutions
  • Proficiency with Microsoft Office Suite
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$85k – $162k / yr

Senior Quality Systems Engineer · Boston Scientific

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