**Software Quality Engineer Development Engineer**
Kelly is looking for a Software Quality Engineer to join an exciting Biotechnology start-up environment! This role has the option of a **hybrid model** but must be able to commute to office if needed in the Laguna Hills area.
**Job Description:**
+ 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.
**Education and/or Work Experience Requirements** :
+ Bachelor of Science degree in Engineering or Life science discipline, Computer Programming, Biomedical, or equivalent technical degree is required.
+ Minimum of 5 years of experience in Quality Assurance, ideally in the medical device industry.
+ Minimum of 3 years of experience in embedded software development and nonproduct 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
**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.
\#P1
**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** **** **Science & Clinical?**
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
