Senior Quality Engineer

Dataroomspot

Quality management systems (qms)
Fda regulations
Device history records (dhr)
The company fosters a culture that unifies, embraces uniqueness, and positions for long-term success through common values

Job Summary

  • The company fosters a culture that unifies, embraces uniqueness, and positions for long-term success through common values.
  • Responsibilities include supporting regulatory inspections, monitoring manufacturing compliance, leading product and process improvement initiatives, and managing complaint investigations.
  • The total rewards program includes base salary, cash incentives, comprehensive benefits with immediate eligibility, 401(k) with company match, holidays, and paid time off.

Matching Summary

The company fosters a culture that unifies, embraces uniqueness, and positions for long-term success through common values.

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • product and process improvement methodologies
  • risk analyses and Control plans
  • product, process, and test method validations
  • inspection techniques and procedures
  • non-conforming materials disposition
  • CAPA activities
  • statistical quality control

Nice-to-have

  • GB Core Beliefs
  • customer success focus
  • innovation and collaboration
  • respectful interaction
  • open and honest communication
  • people management career path

Key Requirements

  • Strong Statistical techniques
  • Use of RCA approaches
  • Excellent Workload management
  • Good Soft skills

Work Rights

Not specified

Tailored Resume

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