Quality Systems Engineer III

3 weeks ago


Austin, Texas, United States Saxon Global Full time
Job Overview:

Saxon Global is seeking a Quality Systems Engineer III to join our team. This is a leadership role that requires a strong background in quality systems, excellent communication skills, and the ability to work effectively in a fast-paced environment.

The ideal candidate will have a minimum of 4 years of experience in a medical device quality assurance environment, with a strong understanding of quality system regulations (ISO13485, 21CFR820) and a degree in engineering, life sciences, or a related field.

The salary for this position is estimated at $105,000 - $125,000 per year, depending on location and experience.

Main Responsibilities:
  1. Drive supplier and production quality improvements, including efficiency and productivity enhancements while maintaining compliance
  2. Develop quality instructions and standards
  3. Suggest, implement, review, and approve engineering changes to support product lifecycle
  4. Support CAPA system for quality operations-related activities
Qualifications:
  • Minimum 4-year degree in engineering, life sciences, or similar
  • 4-6 years increasing responsibility and experience in a medical device quality assurance environment
  • Understanding of quality system regulations (ISO13485, 21CFR820)
  • Knowledge of DOE, SPC, Gage R&R, and sampling plans


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