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 manages the effective process implementation of key quality systems areas related to software development (both product and non-product) to meet or exceed regulatory requirements, quality objectives and business goals. The individual will ensure that the company’s software development and validation processes are designed in accordance with applicable regulations (e.g., FDA) and ISO standards. The individual will collaborate with cross-functional teams, drive process improvements, and champion a culture of quality excellence.This is not a software testing position.Tasks and Responsibilities:Applies a strong knowledge of US FDA regulations and ISO 13485 requirements to the effective implementation of key quality system processes such as Design Controls, Software Life Cycle, Change Management, Cybersecurity and Risk ManagementProviding expertise in ensuring software development procedures are in compliance with regulatory expectations and standards (i.e., IEC 62304)Lead and guide continuous improvement projects for software development process, cybersecurity, software configuration and change management, and related quality processesDevelop & provide training and direction related to software development areas to stakeholders within the organizationIdentify quality system improvement opportunities and drive process updates when requiredDevelop and optimize quality processes, procedures, and work instructions to ensure consistency, efficiency, and adherence to best practicesDevelop, analyze and report quality metrics to assess performance, identify trends, and implement corrective and preventive actions (CAPAs) to address non-conformancesServes as one of the primary resources during internal and third party audits either by directly interfacing with auditors or regulators or providing back room supportProviding direction and guidance on verification and validation of non-product software, products software, software tools and componentsAs needed, provide quality support and oversight to software development project teams focusing on software life cycle processes. This includes (but not limited to) design development, verification, validation, risk management, software configuration management and deployment, including reviews and approvalsEvaluate and/or perform computer system validation for applicable software or GxP computerized systems per Illumina’s internal guidelinesSupport post market activities for software related anomalies, complaints and CAPAs including root cause investigationsImplementation of quality key performance indicator (KPI) improvementsStay up-to-date with industry trends, regulations, and best practices related to Design Controls, Cybersecurity, Software Life Cycle and Risk ManagementAll listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.Education:Bachelor’s degree in Computer Science, Software Engineering, Bio-Informatics, Biomedical (or related discipline) or equivalent experience in lieu of degreeRequirements:Strong knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices3+ years’ experience (SQE2) or 5-8+ years' (Sr SQE) 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)Experience with Software as a Medical Device and Computer System Assurance best practicesAble to deliver quality output under some supervision and with general directionAbility to operate flexibly in a fast-paced environmentProven experience in leading and managing quality programs, driving process improvements, and implementing corrective actionsStrong analytical and problem-solving skills, with the ability to utilize data and metrics to drive decision-making and process improvementsStrong technical writing skills, including the ability to write software development and related procedures and processesExcellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels to drive a culture of QualityProgram/Project Management Experience will be a plusQuality and/or Regulatory Certifications (ASQ, RAPS, AAMI, etc.)Occasional travel may be required#LI-HYBRIDThe estimated base salary range for the Sr. Software Quality Engineer (Process Improvements and Initiatives) role based in the United States of America is: $86,500 - $129,700. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. 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