30 days old

Software Quality Engineer

Kelly Services
Laguna Hills, CA 92653
**Kelly Services is actively recruiting for a Software Quality Engineer for a Direct Hire opportunity in Laguna Hills, CA.**

Responsible for:

+ Leads and supports new product development for adherence to the internal quality management design control system and all ISO, FDA and QSR regulations.

+ Provide regulatory compliance input to the Software development team on quality issues arising during development and risk updates.

+ In this role, it is expected that the Engineer works with R&D engineering to understand design requirements and the intended use of tests in the finished algorithm.

+ With a focus on documenting software development including validating both product and non-product software.

+ Participate in and contribute to formal design reviews, ensuring design control requirements are met during each design phase.

+ Drafts, routes, reviews, and approves procedures, verification & validation protocols, and reports.

+ Verify Configuration Management and Risk Analysis records are properly addressed, accurate, and maintained.

+ Ensure design changes are processed in accordance with current change-control requirements.

+ Complete assigned tasks on schedule and identify and propose resolution for issues that may affect the timeline for remediation activities.

+ Coordinate the resolution of potential quality assurance deficiencies discovered during the product realization process.

+ Lead and support CAPA investigations, reviews, approvals, and/or CAPA plan implementations as required.

+ Lead teams in FMEA and Risk Assessments analysis. Per the Job Level Matrix

Education and/or Work Experience Requirements:

+ Bachelor of Science degree in Engineering discipline, Computer Programming, Biomedical, or equivalent technical degree is required.

+ Minimum of 8 years of experience in Quality Assurance, ideally in the medical device industry.

+ Minimum of 3 years of experience in embedded software development and non-product software validations, ideally in the medical device industry.

+ Demonstrated applied experience in FDA 21 CFR 820 and medical device regulations ISO 13485 and ISO 14971 as applied to medical device software

+ Experienced in AGILE software development process, ideally proficient/SME level.

+ Working knowledge of IEC 62304 and ISO TIR 45.

+ Experienced in non-product software assessment, validation, and management, ideally proficient/SME level. Working knowledge of ISO TR 80002-2.

+ Experienced in Risk Management and Design Control of Medical Devices, ideally proficient/SME level.

+ Experience with Automated testing, unit/integration/system test, Jenkins, JIRA,

+ SharePoint, and Confluence

Experience with the below:

+ Program Languages: MS VB, C++/#, Python, C#, JavaScript, HTML, XSL, XSLT, XML

+ Database: SQL, MySQL, UNIX, LINUX, Oracle 8i, 9i Enterprise, Red Hat

+ Web-based Apps: HTML, .NET, XML, Java EE, .NET, JavaScript, HTML, XSL, XSLT, XML, ICloud, QT

+ Candidate should have demonstrated technical leadership skills in a multi-discipline engineering project environment.

+ BONUS Knowledge of electrical engineering, not required Per the Job Level Matrix

Interpersonal skills requirements:

+ Must be able to work independently leading Quality efforts.

+ Must be able to work effectively and collaborate within cross functional teams.

+ Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.

+ Must have strong math skills, strong statistical skills preferred.

+ Must have strong documentation skills and competency with MS Office.

+ Must take initiative and ability to conduct hands-on work.

+ Must possess the ability to handle multiple tasks with high attention to detail.

+ Physical ability to lift 10-25 pounds and sit, climb, balance, stoop, kneel, and crouch.

+ Superior organizational and communication skills

+ Good Written and Verbal skills.

+ Able to take direction and execute plans

**If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2022-06-03 Expires: 2022-07-04

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Software Quality Engineer

Kelly Services
Laguna Hills, CA 92653

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