Senior Quality Assurance Specialist
2 days ago
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
- 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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