Senior Quality Engineer

Job Summary

A company is looking for a Senior Quality Engineer to lead verification and validation processes for medical devices.

Key Responsibilities

• Lead verification, validation, and maintenance of systems supporting medical devices
• Develop and maintain computer system validation policies and procedures
• Collaborate with cross-functional teams to define testing strategies and execute tests

Required Qualifications

• BA/B.S. or higher in Computer Science, Software Engineering, Informatics, Biomedical, or related fields
• 5+ years of experience in an FDA regulated domain (medical device, pharma, biotech)
• 3+ years of experience in Computer System Validation (CSV)
• Familiarity with industry standards for medical device software and CSV, including ISO 13485 and FDA regulations
• Ability to deliver quality outputs with minimal supervision