Sr. Software Quality Engineer

This position will support quality activities and projects to successfully meet department and corporate goals. This position will require a mastery of understanding, interpreting, and implementing FDA and international regulations and using the guidance to create and maintain department procedures. Key contributors in authoring and leading the development life cycle of a project., * Maintain the Quality Management System and evaluate software and business processes to comply with existing and new FDA and International regulations.

• Ability to lead a project’s software development lifecycle as the Quality Lead.
• Author documentation and provide guidance throughout the entire Software Development Life Cycle (GxP, Part 11, Requirements, Validation, and Summary documentation).
• Provide mastery guidance on the proper use of wording for a requirement and provide test guidance on its testability.
• The ability to understand large enterprise systems and experience working as a Quality Engineer with large enterprise software systems such as (SAP, Cloud PLM, Oracle, Camstar, etc.)
• Communicate with teams and provide quality guidance on a project team.
• Be able to learn technical jargon quickly and communicate with software engineers and IT.
• Communicate with small teams, peers, and management.
• Provides guidance and support with Quality solutions affecting and defining the Quality Management System.
• Supports new regulation gap analysis and updates to the Quality Management System.
• Support IT enterprise systems infrastructure, complex IT systems, implementation, deployment, post-improvements, and maintenance.
• Ensure compliance with Domestic and International quality management systems.
• Supports continuous improvement and review of the Quality Management System.
• Create and approve complex system test case scripts, automation scripts, approvals, and validation support.
• Create engineering deployment and network diagrams for the system and applications.
• Provides guidance on data migration planning, scripting, and reporting.
• Works closely with IT and Quality to ensure compliance with numerous agencies and requirements

• Must have 3 - 5 years of experience working within a regulated environment.
• Must have experience interpreting FDA guidance and translating that information into SOPs and process instructions for the company.
• Direct experience with Quality Management Systems, Enterprise Computer Systems risk management, and validations preferred.
• Must be able to present to small teams.
• Collaborative, able to work effectively with diverse functional groups.
• Must demonstrate diligence for compliance, technical competence, and sound judgment associated with each essential duty and responsibility.
• Must have experience guiding teams during validation activities.
• Experience understanding workflow and deployment diagrams.
• Experience working in a Quality capacity on large multi-layered Enterprise level systems

Preferred:

• Data mining, R statistical computing, tableau, PowerBI
• AI governance, AI Validation