Looking for a Software Quality Engineer for our San Antonio TX location.
Main Criteria : Working knowledge of FDA and IEC 62304 requirements for medical device software, Working knowledge of C, C++, and LabVIEW
Level 1 is at max 67000, Level 2 is at max 90000
Job Description :
Ensures compliance to regulatory requirements and applicable industry standards and guidance for software development, verification and validation (V&V) processes associated with medical device embedded software. This individual will participate in code review, audit software documentation against established software processes and work standards, and verify software anomalies align with the risk management requirements.
Responsibilities :
* Work with software/firmware designers and developers at all stages
of development to conform to software life cycle procedures including
risk management.
* Approver of software development documents, software V&V
documents, and quality system procedures for device software.
* Audits software test procedures (including automated testing) to
verify against software requirements specification.
* Audit software development process against regulatory
requirements, standards, industry guidance, quality system procedures,
work instructions, templates, and project development plans.
* Facilitate discussions with Software Developers to triage and
resolve anomalies identified during testing.
* Facilitate the use of current Software Quality techniques. Ensure
compliance of new products to internal process requirements, industry
standards (e.g. ISO, IEEE, IEC), and regulatory agency requirements.
* Participate in design and code review meetings relating to
embedded systems.
* Document/Oversee the software verification and validation of the
product. Manage/Oversee product documentation through the Change Order
and Release process.
* Contribute to system level hazard analysis and generate test
guidelines for software products and/or the tools used in software
development.
* Immediately elevate to management any major problem with device
software that could affect data security, customer usability or system
adherence to process requirements.
* Support the supplier audit process, as applicable, as a subject
matter expert in the auditing of embedded systems/product software
providers
* Execute process improvement projects, as required
* Participate in any and all reasonable work activities as may be
deemed suitable and assigned by management.
* Conform to, support and enforce all Company policies and
procedures.
* Perform other duties/responsibilities as assigned by management
Job Type: Contract