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