Staff Quality Engineer Product Quality

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Job Function:
R&D Product Development

Job Sub Function:
R&D Software/Systems Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Boston, Massachusetts, United States of America, Gières, Isere, France, Raynham, Massachusetts, United States of America

Job Description:

The Staff Quality Engineer, Product Software Development, will provide quality leadership on new product project teams responsible for the development of medical device software systems.

The Staff Quality Engineer will be the subject matter expert in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.

DUTIES & RESPONSIBILITIES


* Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products.



* Provide leadership, guidance and expertise on the software development process, procedures and practices.

Enhance processes to better reflect state of the art practices and drive continuous improvement.



* Partner with R&D to refine requirements, and to ensure that architecture/ design documents are comprehensive.



* Facilitate the documentation and tracking of verification activities, including code review findings.



* Review test case execution results and manage defects.



* Facilitate software risk assessment sessions and own the development of risk documents.



* Support regulatory filings and registrations.



* Support internal and external audits or inspections of SaMD products and processes and own Non-conformances or CAPAs and drive root cause investigations.



* Provide technical support for audits of software suppliers and software consultants.



* Conduct training on Medical Device Software development processes and quality systems.



* Train and mentor new engineers and lower-level quality engineers.



* Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, IEC 62366, ISO 27001, and HIPAA.



* Provide guidance to pro...