Software Quality Engineer

Software Quality Engineer 2 page is loaded## Software Quality Engineer 2locations:
US - California - San Diegotime type:
Full time posted on:
Posted 6 Days Agojob requisition :
41585-JOB## At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.## Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference.

Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.##
** Responsibilities:
*** Provide ongoing software quality engineering support throughout the software development life cycle
* Provide support to development, engineering and manufacturing functions for validation planning and transfer activities
* Assist teams in determining verification and validation needs and requirements
* Provide support for software development projects in the manufacturing areas by review/approval of software deliverables:  + Software Development Plans, Verification Plans, Validation Plans  + User Requirements, Functional/Software Requirements  + Configuration Specifications, Software Architectural and Design Documents,  + Peer Reviews  + Risk Management Documents  + Test Protocols, Requirement Traceability Matrices, Summary Reports
* Provide review and approval of software related change orders
* Ensure successful transfer of software from development into manufacturing product support
* Participate in software the risk management process throughout the entire software lifecycle
* Ensure compliance of validation efforts performed by internal/external validation personnel
* Provide quality assurance support to software related CAPAs
* Identify and make recommendations for improvements to the Software Quality Assurance Program
* Assist in the development and delivery of training to employees on principles of software validation, software risk management, and general quality tools
* Responsible for escalating potential risks to management
* Responsible for exhibiting professional behavior with both internal/external business associates that reflect positively on the company and is consistent with the company’s policies and practices
* Other such duties as may be determined by Management
** Requirements:
*** 3+ years Software Quality Engineering or relevant experience
* Certified Software Quality Engineer preferred (e.g., CSQE)
* Experience in a regulated environment, in vitro diagnostics/medical device
* Experience and working knowledge of applicable regulations and standards:
* 21

CFR 820, 21

CFR Part 11, ISO 13485, IEC
62304, ISO
14971, GAMP5
* Working knowledge of Software Development Life Cycle Models
* Working knowledge of Software Configuration Management (SCM)
* Experience with a variety of software categories desirable (e.g. COTS, Configurable, Custom)
* Experience with software verification and validation
* Experience with the application or risk management tools
* Understanding of software development, inspection, and testing
* Working knowledge of spreadsheets and word processor applications
* Excellent attention to detail, strong organization skills, and ability to work independently and in teams
* Excellent interpersonal, verbal and written communication skills
* Ability to operate flexibly in fast-paced environment
* Able to deliver quality outputs under minimal supervision
* Experience with statistics, sampling plans, and statistical analysis

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.  Changes to individual responsibilities may occur due to business needs.
** Experience/

Education:

*** Typically requires a Bachelor’s degree and a minimum of 3 years of related experience; or equivalent work experience.### The estimated base salary range for the Software Quality Engineer 2 role based in the United States of America is: $73,400 - $110,200. Should the level…