Job Directory QA Software Quality Specialist

QA Software Quality Specialist
Cambridge, MA

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Job Description

QA Software Quality Specialist

Overview:

Foundation Medicine is dedicated to helping bring personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine is developing clinical laboratory tests that will broadly capture the most relevant tumor genomic and other molecular information in a single test, and connect it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient.

We are seeking a talented and highly motivated software quality specialist to support the development and review of documentation for regulatory submissions.

Your Impact:

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 to ensure 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.

Responsibilities:

* You're someone who can 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.
* You will review and approve documented deliverables from the SDLC process for use in regulatory submissions.
* You will provide guidance on the application of SDLC standards.
* You will perform internal audits of SW projects and external audits of suppliers.
* You will participate in the creation and updating of processes and work instructions.
* You will advise on and review Computer Systems Validation activities.
* You'll need to 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.

Qualifications:

* Understanding of software engineering and development and experience in a relevant department that has software as part of a medical device.
* Direct experience working with Regulatory, QA and software development teams.
* Demonstrated and significant contributions to an FDA 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.
* Familiarity with software documentation artifacts such as Requirements Documents, Software Detailed Design Documents, Software trace matrix documents and software Architectural design documents.
* Familiarity with Computer Systems Validation methods and standards.
* The person should understand software coding constructs and systems such as Confluence, JIRA and various script languages such as Python.
* Understanding of agile SW development.
* Knowledge on SW version control and version management.
* Knowledge of FDA SW regulations, Part 11, Part 820, Part 812, part 814; IEC 62304.
* Able to work in an environment that can change quickly and may be loosely structured at times.

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.

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