Engineer, Software Quality

Title: Engineer, Software Quality

Location: Lake Forest, IL

Duration: 1+ Years

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 healthcare 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
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.