Validation Software Engineer

Title: Sr Software Quality Engineer - Remote

Duration: 6 Months

Location: Remote

Travel Required:

• Up to 25%

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Description:

Position Summary:

The main function of a quality engineer is to research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards. A typical quality engineer has the ability to read and interpret blueprints, and evaluate product integrity and standards. 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. Support and collaboration for one or more areas of business support software, and IT compliance, including, but not limited to:

• Maintaining the Quality Management System, FDA, and International Regulation and Standards.

• Providing expert guidance to teams working within an FDA-regulated environment.

• Mapping and creating diagrams for enterprise systems.

• Creating system and functional risk assessments, requirement documentation, validation plans, and reports.

• Supporting software development project teams.

• Continuous Improvement.

• Additional quality responsibilities as assigned.

• Have a mastery level understanding of the Software Development Life Cycle (SDLC).

Duties and Responsibilities:

• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.

• Establishes program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.

• May write training material and conduct training sessions on quality control activities.

• May specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, research and development, and administrative application.

• 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 Essential Skills:

• 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.

• Creativity, verbal and written communication skills, analytical and problem solving ability.

• Team player and detail oriented.

• Basic ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.

• Basic experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Experience and Education Requirements:

• Typically requires a bachelor’s degree in a technical discipline, and 2 – 7 years of related work experience.

• Experience working within a regulated environment required, with some prior team lead or managerial experience preferred.