Software Quality Engineer II, Fresenius USA Manufacturing, Inc., a Fresenius Medical Care N.A. company, Lawrence, Massachusetts (Remote)

Purpose and Scope:

Responsible for ensuring that Fresenius’ regulated computer systems are developed, validated, and maintained in compliance with corporate software validation lifecycle policies and procedures.

Principal Duties and Responsibilities:

• Partnering with business teams and IT to ensure that computerized quality systems are compliant with Fresenius procedures, FDA Quality System Regulations, 21 CFR Part 11, and GAMP5.
• Creating and overseeing the creation of validation deliverables including, but not limited to, validation assessments, validation plans, test plans, test protocols, test reports, validation summary reports, and trace matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment. Leading the review and approval of validation deliverables.
• Executing test protocols as necessary. Conducting independent reviews of test executions.
• Assisting business owners/teams and IT in the definition and creation of business requirements, functional specifications, and system specifications.
• Compiling and maintaining approved project deliverables.
• Communicating project and compliance issues to Quality Systems management.
• Presenting and defending system validation projects and documentation during internal and/or external audits and FDA inspections as a Subject Matter Expert.
• Providing guidance and direction to external contractors working on system validation projects.
• Ensuring that pertinent validation deliverables are of high product quality and are compliant with Fresenius policies and procedures.

Education Experience and Required Skills:

Bachelor’s degree (or an equivalent foreign degree) in Computer Science, IT, Electrical or Electronics Engineering or a closely related field and 1 year of experience as a Software Developer or Software QA Engineer. Must have had 1 year of experience (which can have been gained concurrently with the primary experience requirement above) working with object oriented architecture, Oracle & MySQL databases, Linux OS and Linux scripting. Must also have had experience (including academic coursework or projects or internship experience) with (i) automated testing using Selenium Framework, (ii) web security, SOAP, HTML5, XML and (iii) AWS Cloud including EC2, EBS, IAM and RDS.

Will accept any qualified combination of education, training and/or experience.

This is a telecommuting position working from home. May reside anywhere in the United States