What if the work you did every day could impact the lives of people you know? Or all of humanity?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.Position Summary:The Software Quality group is a highly specialized group within Design Quality. The Software Quality Engineer 2 provides support to Illumina’s software development teams to ensure that the company’s product software is designed in accordance with Illumina’s policies/ procedures and applicable regulations (e.g. FDA) and ISO standards.This is not a software testing position.Tasks and Responsibilities:Provide quality support to new and sustaining product development teams focusing on software life cycle processes within design control. This includes design, verification, validation, risk management, software configuration management and deployment including reviews and approvalsDrive software risk management activities in accordance with industry standardsEnsure quality and completeness of design history files for softwareDevelop and conduct training on software life cycle framework to software developers, testers and other stakeholders within the organizationParticipate in strategic/technical discussions and risk-based decision makingEnsure SLC processes meet quality and regulatory requirements and identify areas and opportunities to improve quality system processesSupport post market activities related to product software anomalies - Complaint Handling, MDR’s, CAPAsTrend, analyze, and report on quality data to improve product and processAll listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Preferred Education:Bachelor’s degree in Computer Science, Software Engineering, Bio-Informatics, Biomedical or related disciplinePreferred Requirements:Working knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices2+ years’ experience in (software) design quality engineering or related role in a medical device / IVD company environmentWorking experience with relevant industry standards (ISO 13485, ISO 14971, IEC 62304)Able to deliver quality output under some supervision and with general directionAbility to operate flexibly in a fast-paced environmentPartners with other functions (Product Development, Testing, Validation, etc.) to drive a culture of QualityWorks to identify, correct, and prevent obstacles in assurance of product software qualityGood interpersonal, verbal and written communication skillsApply Quality Engineering principles (structured development process, risk management, etc.) effectivelyQuality and/or Regulatory Certifications (ASQ, RAPS, AAMI, etc.) (preferred)Occasional travel may be requiredIllumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
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