Software Quality Engineer II, Fresenius USA Manufacturing, Inc., a Fresenius Medical Care N.A. company, Waltham, MA (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:

• Representing the Quality Systems department on software development teams as the software validation subject matter expert.
• Partnering with and/or leading business team and IT to ensure that computerized quality systems are compliant with Fresenius procedures, FDA Quality Systems Regulations, 21 CFR Part 11 and GAMP5.
• Leading and coordinating multiple software validation projects across the Fresenius enterprise.
• Creating and/or 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 an FDA-regulated environment. Leading the review and approval of validation deliverables.
• Developing and creating test protocols as necessary. Conducting independent reviews of test executions.
• Leading business owners/teams and IT in the definition and creation of business requirements, functional specifications, and system specifications, as necessary.
• Compiling, maintaining, and evolving approved project deliverables.
• Communicating project and compliance issues to Quality Systems management and providing solutions to potential risks.
• Developing and managing internal and external regulatory audits/inspections by presenting and defending system validation projects and documentation during audits and FDA inspections as the subject matter expert.
• Providing guidance and direction to external contractors working on system validation projects.
• Ensuring that all pertinent validation deliverables are of high product quality and are compliance with Fresenius policies and procedures.
• Working with little to no supervision to fulfill duties in accordance with requirements of the QSR regulations, GAMP5, and corporate policies and procedures.

Education Experience and Required Skills:

Position requires a Bachelor’s degree (or an equivalent foreign degree) in Computer Science, Electrical or Electronics Engineering, IT or a closely related field and 5 years of experience as a Software Quality Engineer. Must have 5 years of experience (which can have been gained concurrently with the primary experience requirement above) working with: the computer system validation process; 21 CFR Part 11 and GAMP5; Microsoft SQL; and HP Application Lifecycle Management (ALM). Must also have had experience (which can have been gained concurrently with the requirements above) working with:

• TrackWise;
• Global Safety System – ArisG;
• ServiceNow and Cloud Implementation; and
• 21 CFR Part 820.

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