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Software Quality Assurance Engineer

Ultimate Irvine, CA Contractor
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We are seeking a Software Engineer who has experience working with a quality/compliance team. The ideal candidate will bring software development along with a quality assurance/compliance aspect. This position is with a small, dynamic team in a very fast paced environment that is evolving and changing quickly. The right candidate should be flexible and quick to adjust to changes. This is an exciting opportunity with a global medical device company working on a pioneering project for the company. 

Key Responsibilities:
* Lead and support all facets of quality engineering through all stages of software product lifecycle (Design, Verification and Validation Testing, Release, and Post-Market) for stand-alone, cloud-based software medical devices and platforms.
* Provide guidance and represent software quality engineering in cross-functional review meetings including design review, operations change review, post market surveillance review, and cybersecurity review
* Develop, update, and maintain technical contents of risk management files and software Design History Files (DHF)
* Develop and maintain department quality and cybersecurity training materials and records
* Support cybersecurity team in conducting security review, updating and maintaining security policy and procedure to meet relevant industry standards and regulations (HIPAA, GDPR, HITRUST, etc.)

Top Skills:
*  Quality assurance/compliance coupled with software development
* Familiarity with software development lifecycle (e.g. Agile Methodology, IEC 62304)
* Experience with Software as Medical Device (SaMD)
* Information Security/Cybersecurity- support security review and security risk assessment
* Risk Management- perform risk assessment and maintain software product risk management files
* Experience in Agile software development, software development lifecycle, software quality and/or software V&V is preferred
* Knowledge and experience with quality systems and processes is preferred
* Knowledge and experience with cybersecurity is preferred
* Knowledge of applicable FDA regulations for medical device industry
* Ability to manage competing priorities in a fast paced environment
* Ability to be flexible and quick to adapt to changes within a small, dynamic team

Education/Required Experience:
* Bachelor's Degree or equivalent in an Engineering or scientific field and 5 years of experience (Required) OR Master's Degree or equivalent in Engineering or scientific field and 3 year of experience (Required)
* Software engineer with quality/compliance experience

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Recommended skills

Software Design
Software Development
Software Development Life Cycle
Verification And Validation (Software)
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Job ID: JO-2005-90554


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