Senior Quality Assurance Specialist

2 days ago


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

Saxon Global seeks a highly skilled Senior Quality Assurance Specialist to join our team. This is a challenging role that requires a strong background in quality assurance, 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). A degree in engineering, life sciences, or a related field is required.

The salary for this position is estimated at $95,000 - $110,000 per year, depending on location and experience.

Key Responsibilities:
  • Participate in nonconformance processes to ensure timely completion of documentation stages
  • Identify, report, and monitor nonconforming events
  • Perform product or process failure investigations and implement corrective actions
  • Collaborate with cross-functional teams to resolve quality issues
Requirements:
  • 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)
  • Mechanical aptitude
  • Knowledge of DOE, SPC, Gage R&R, and sampling plans


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