Staff Quality Engineer – Illumina, Inc. – Santa Clara, CA

Job ID: 2904
Job date: 2015-03-03

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Job Description:
Join one of biotech's most successful companies to support teams that create world-class software with the best and brightest in the industry. Illumina is challenging talented software designers to deliver the software solutions which decipher the essence of biological structure and human disease.

There has been an exponential growth in the production of genomics data, thanks to the plummeting cost of generation of this data. We are looking for a hands-on software quality/assurance engineer to join Illumina’s fast growing engineering and QA team. We are the world leader in genetic analysis instrumentation — and our software enables and improves the analysis of the data produced by those instruments.

The position of Staff Quality Engineer will provide quality assurance support to software development teams and global Quality Management System (QMS). As a key member of the Software Quality department, this individual will be responsible for establishing and ensuring compliance to Illumina quality policies and procedures.

Responsibilities:
Establish and maintain SDLC processes and SDLC tools Establish and maintain software related Quality Management System (QMS) process and procedures. Assist with post-market defect/complaint handling and investigations, CAPAs and other QMS activities such as audits, training and document control. Train and mentor teams to the usage of SDLC and QMS in their respective projects and functions Ensuring compliance to SDLC and QMS across the business unit Act as liaison and work closely with the global quality organization to implement QMS within the business unit and integrate it with the global QMS Compile and maintain DHF (Design History File) in a dynamic, Agile/Scrum environment with frequent releases SRS, SAD, SDD, traceability, risk management, and V&V protocols & reports. Develop software risk management process throughout entire product lifecycle Assist with validation efforts performed by internal/external validation personnel.

Required Skills and Experience
5-7 years software quality assurance experience Experience with Medical Device Software Experience with SDLC; Agile/Scrum methodology in a regulated environment preferred Experience with FDA QSR/ISO 13485 QMS, including CAPA, root cause analysis and complaint handling/investigations. Experience with the application of ISO 14971 risk management Understanding of software configuration management and other SDLC principles Working knowledge of software validation. 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 Preferred Educational Background:

BS/BA or equivalent in Computer Science, Engineering, Biological/Life Sciences, or related field required Experience in FDA regulated environment, medical device preferred Working knowledge of applicable standards and regulations, including 21 CFR Part 820, Part 11, ISO 13485, IEC 62304, AAMI Standards, ISO 14971 Experience with a variety of software categories desirable Understanding of basic molecular biology and bioinformatics desirable
EOE / Minorities / Females / Veterans / Disabled

About Illumina

Headquartered in San Diego, California, Illumina (NASDAQ: ILMN), is a leading developer, manufacturer, and marketer of next generation life science tools and integrated systems for large-scale analysis of genetic variation and biological function. These systems are enabling studies that were not even imaginable just a few years ago, and moving us closer to the realization of personalized medicine. With the innovative advances in our sequencing technologies, we are rapidly impacting the clinical market in areas such as reproductive health and oncology. The expanding Illumina oncology portfolio of next- generation sequencing NGS and microarray technologies is revolutionizing cancer genomics research. Our customers include a broad range of academic, government, pharmaceutical, biotechnology, and other leading institutions around the globe.

lllumina has experienced phenomenal growth from $10 million in revenues in 2002 to over $1.4 billion in 2013. Forbes named Illumina #1 on the 2009 list of 25 Fastest-Growing Technology Companies in the United States, the second time over a three year period that Forbes ranked Illumina #1 on its list of rapidly growing technology companies. Illumina was also named #1 smartest company in the world as part of MIT’s 2014 Technology Review. As of August 2014, the company had a $24 billion market capitalization.


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