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Fresenius Medical Care North America Senior Software Quality Engineer in Waltham, Massachusetts

Senior Software Quality Engineer, Fresenius USA Manufacturing Inc., a Fresenius Medical Care N.A. company, Waltham, MA (Remote)

Purpose and Scope:

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

Principal Duties and Responsibilities:

  • Leading and coordinating multiple software validation projects across the Fresenius enterprise.

  • Partnering with and/or leading business teams and IT to ensure that computerized quality systems are compliance with Fresenius procedures, FDA Quality System Regulations, 21 CFR Part 11 and GAMP5.

  • Representing the Quality Systems Department on software development teams as the software validation subject matter expert.

  • Creating and overseeing the creation of validation deliverables, including validation assessments, validation plans, test plans, test protocols, test reports, validation summary reports, and trace matrices, 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.

  • 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 and inspections by presenting and defending system validation projects and documentation during audits and FDA inspections.

  • 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 in compliance with Fresenius policies and procedures.

Education Experience and Required Skills:

Position requires a Bachelor’s degree (or an equivalent foreign degree) in Computer Science, IT or a life sciences field including Pharmaceutical Science and 5 years of experience performing software validation and testing in the life sciences sector. Must also have 5 years of experience (which can have been gained concurrently with the primary experience) working with the following:

  • The FDA Quality Systems regulations and their application to computer system validation including writing test protocols, executing validation testing, creating and maintaining traceability matrices and writing validation reports;

  • Defining and performing verification for data migration;

  • Software Development processes with Agile methodologies and SW LifeCycle (SDLC) using ServiceNow, Jira and Azure DevOps;

  • Enterprise-wide systems for ERP, Document Management and Product Lifecycle Management including SAP, Windchill and Veeva Vault;

  • Automated test scripting tools including Katalon and Continua.

Must have strong verbal and communication skills.

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