About the Job

The Software QA Engineer II is part of a team responsible for Quality Assurance of the genomics platform that powers every test at Foundation Medicine. The scientists and engineers in the group collaborate with other teams to enrich the analytical capabilities of existing products as medical knowledge advances, as well as to design and build lab protocols and computational analyses for new products. QA is responsible for safeguarding the software development lifecycle and for ensuring compliance for all SW products. The Software QA Engineer II is responsible for understanding SW workflows in our genomics pipeline, supporting regulatory and partner audits in the area of IT and computer systems validation, and contributing to many of the projects we undertake, all of which have direct impacts on patient care.

You will join a team responsible for Quality Assurance of the genomics platform that powers every test at Foundation Medicine. The scientists and engineers in the group collaborate with other teams to enrich the analytical capabilities of existing products as medical knowledge advances, as well as to design and build lab protocols and computational analyses for new products. QA is responsible for ensuring compliance for all SW products. You will contribute to many of the projects we undertake, and those efforts will have direct impacts on patient care.

Key Responsibilities

• Aid the software development teams with formulating well-articulated documents that those external to the development process, without a software background, will understand at a high level.

• Review and approve documented deliverables from the SDLC process for use in regulatory submissions.

• Provide guidance on the application of SDLC standards.

• Perform internal audits of SW projects and external audits of suppliers.

• Participate in the creation and updating of processes and work instructions.

• Work with SW development teams to plan and execute software releases.

• Advise on and review Computer Systems Validation activities.

• Liaise with Foundation Medicine’s Quality Assurance department on software deliverables to facilitate discussions between different Software engineering teams and Quality Assurance to quickly come to agreement on scope and detail required for Software documentation for regulated products.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree in computer science, software engineering, or life sciences

• 5+ years of prior experience with quality systems and/or SW quality for medical device or healthcare software development

• 2+ years of prior experience with Agile SW development practices

Preferred Qualifications

• Master’s Degree in computer science or software engineering

• Direct experience working with Regulatory, QA and software development teams

• Experience acting as subject matter expert during regulatory audits

• Experience with Computer Systems Validation methods and standards

• Demonstrated and significant contributions to a regulatory software submission

• Solid understanding of SDLC, familiarity with Software Requirements Documents, Software Detailed Design Documents, Software trace matrix documents, software Architectural design documents, and risk assessment documentation as either an author of these documents or as someone who has reviewed them regularly

• Knowledge on SW version control and version management

• Knowledge of relevant medical SW regulations: 21CFR Part 11/annex 11, Part 820, Part 812, part 814; IEC 62304, ISO 14971, ISO 13485, EU IVDR, ISO 27001 & ISO270017, and FDA & MDCG cybersecurity guidance.

• Understanding of software coding constructs and systems such as Confluence, JIRA and various script languages such as Python

• Understanding of software engineering and development and experience in a relevant department that has software as part of a medical device

• Ability to work in an environment that can change quickly and may be loosely structured at times

• Ability to provide compliance guidance to Software development teams

• Understanding of HIPAA and/or GDPR and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion