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Software Quality Engineer
4 months ago
Internal Title: Software Quality Engineer
Duration: 12-month contract
Location: Onsite in Lake Forest, IL
Responsibilities:
- Responsible for providing technical, documentation, and implementation support for our Systems and applications.
- Effectively assess regulatory and validation requirements for computer systems within organization
- Identify and develop all required computer system validation deliverables including but not limited to validation plan, user and functional requirements, regulatory requirements, test strategy, IQ/OQ, deployment plan, traceability matrix, validation summary and others
- Ensures compliance to all relevant Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
- Experience in ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer System Assurance
- Provide verification/validation activities project estimates per the department operating procedures.
Qualifications:
- Bachelor degree in Computer Science, Information Technology, Healthcare Technology, Life Sciences, or related discipline.
- Knowledge of regulations and standards that affect the health care industry.
- 5+ years combined experience in software development, validation, and/or quality systems in a regulated environment.
- Experience in leading software validation efforts, providing software quality assurance support, providing quality system support to IT systems in GxP quality systems for IT, Pharma, or Device industry.
- Experience with writing & executing all computer system validation deliverables
