Software Quality Engineer Location: Lake Forest, IL Duration: 24 months with possible contract to hire Description: Position Summary: The Software Quality Engineer will be based in IL OR California and will be responsible for providing technical, documentation, and implementation support for our Systems and applications. This position is also expected to understand and exhibit the importance of adhering to regulations (i.e. SOX, FDA, HIPAA, PCI, etc.) and is responsible for contributing to regulatory compliance. The role is expected to cultivate, grow, and maintain core principles including, but not limited to, continuous improvement, self-organization, adaptive planning, and value driven development, using methodologies and frameworks such as LEAN, SCRUM and others. Additionally, you will possess a growth-mindset, be team-oriented, have strong interpersonal skills, and possess the ability to deal with ambiguity; applicants must also demonstrate an aptitude for team communication and collaboration Key Responsibilities also include: 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. Develop, own and execute to well defined timeline and project plan Manage compliance, deliverables/templates and ensuring timely completion Responsible to maintain a compliance and consistency across teams and projects across sites Ensure compliance through corporate level policies, supporting tools and training Create, develop, and report metrics on the ongoing and pipeline projects Provide support for external and internal audit activities, including audit process expertise, information repository sources, and inspection readiness including the audit lifecycle process Coordinate Cybersecurity and Data Integrity actions for sites Identify gaps and actions with milestones Ensure all milestones are achieved on time Establish and execute to the escalation process for issues and concerns Help plan and execute Lean Process Projects, as assigned, across multiple sites Qualification: 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 Ability to work on multiple projects and timelines concurrently in a global team set-up Proven expertise in problem solving and identifying solutions in regulated environment Ability to work in matrixed environment Multitasks, prioritizes and meets deadlines in timely manner. Ability to maintain regular and predictable attendance Job Details: JR role- expected to complete validation of the software at the sites, includes creating deliverables, coordination with multiple teams, ensuring communication is clear and brings all on the same page on the projects, able to identify risk proactively, matrixed environment (full validation and involves multiple stakeholders) This is for software validation, not systems validation. Will work with any software that goes into medical devices and any software used as manufacturing equipment, of clinical trial management systems, CAPA management software, etc. Will work with product software and non-product software. Will have owners across different teams. Could be some global interaction. Top Qualifications: Has 5+ combined experience in software quality and validations (preferred all 5 yrs experience in med device or pharma regulated environment. Will consider minimum of 3 yrs experience in regulated environment). Cyber security and data integrity experience. FDA submission experience would be a plus. Prefers to hire someone with Client experience but open to any med device or pharma regulated experience. Preference with someone with product software experience Bachelor's degree required will consider other d