{"id":96079,"url":"https://alion.io/job/illumina-staff-software-quality-engineer-product-development","title":"Staff Software Quality Engineer – Product Development","company":{"id":4262,"name":"Illumina","domain":"illumina.com","url":"https://alion.io/company/illumina","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":84,"open_postings":14,"ghost_share":0,"stale_share":0.643,"repost_share":0,"time_to_fill_p50_days":41,"computed_at":"2026-10-26T05:57:25Z"}},"role":"QA","role_family":"QA","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":23000,"max_usd":51000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":214},"experience_years_min":8,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-08-21T00:00:00Z","employer_posted_date":"2026-08-21","last_verified_at":"2026-10-25T08:10:44Z","board_verified":true,"closed_at":null,"days_open":66,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":66},"description":"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:\nThe Staff Software Quality Engineer serves as a senior quality partner to software product development teams, providing technical leadership and oversight to ensure software products are developed in compliance with company quality requirements, applicable regulations, and industry standards.\nThe role influences quality strategy and practices across complex product programs, mentors engineers, and partners with cross-functional teams to drive risk-based decision making, continuous improvement, and quality excellence in emerging technology areas, while remaining an individual contributor.\nTasks and Responsibilities:\nProvide software quality leadership across multiple product development programs throughout the Software Development Life Cycle (SDLC) and Product Development Process (PDP). \nProvide quality oversight and guidance for software development, verification, validation, cybersecurity, risk management, and product release activities. \nReview and approve software lifecycle deliverables, including requirements, design documentation, traceability records, risk management documentation, verification and validation documentation, cybersecurity documentation, and software change records. \nLead resolution of complex software quality, compliance, and risk management challenges using a risk-based approach. \nInfluence key product development decisions by applying software quality engineering principles, regulatory expectations, and practical understanding of product risk. \nFacilitate quality alignment across Software Development, Product Security, Regulatory Affairs, Product Management, and Program Management functions. \nDrive consistency and improvements in software quality processes, tools, templates, and practices across product teams. \nLead or support software risk management activities throughout the product lifecycle. \nSupport complaint investigations, CAPA activities, audit observations, software nonconformances, and corrective action initiatives. \nProvide quality guidance for cloud-enabled, cybersecurity-related, AI-enabled, and data-driven software solutions, as applicable. \nAssess emerging technologies, development methodologies, and industry trends to identify quality and compliance improvement opportunities. \nDevelop and promote best practices, guidance materials, and reusable quality frameworks that improve organizational effectiveness. \nMentor and coach Software Quality Engineers and cross-functional stakeholders on software quality processes, regulatory expectations, and risk-based decision making. \nAct as a trusted advisor within the Software Quality organization, helping shape future quality capabilities, operating practices, and organizational best practices. \nSupport internal and external audits and act as a subject matter expert for software quality-related topics. \nIdentify organizational risks, quality concerns, and process improvement opportunities, escalating as appropriate. \nContribute to strategic initiatives that strengthen software quality capabilities across the organization. \nSupport other areas of the Quality System and perform additional tasks as defined by management. \nAll listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.\nPreferred Education:\nBachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline\nJob Requirements:\n8+ years of experience in software quality engineering, software development, systems engineering, or a related discipline within a regulated industry. \nWorking knowledge of applicable regulations and standards, including IEC 62304, ISO 13485, QMSR, FDA regulations, and software risk management practices. \nStrong understanding of software verification, validation, risk management, cybersecurity, and quality system requirements. \nExperience supporting regulated software products, including Software as a Medical Device (SaMD), cloud-based software solutions, or complex software-enabled systems. \nDemonstrated ability to influence technical and business decisions without direct authority. \nExperience leading complex cross-functional initiatives involving multiple stakeholders. \nExperience mentoring engineers or cross-functional partners on software quality practices and regulatory expectations. \nStrong analytical, problem-solving, and decision-making skills. \nExcellent verbal and written communication skills with the ability to communicate effectively across technical and non-technical audiences. \nExperience supporting internal and external regulatory inspections and audits preferred. \nQuality and/or Regulatory Certifications (ASQ, AAMI, RAPS, etc.) preferred. \nOccasional travel may be required. \nWillingness to work in shifts to support the US region (No night shift required).\nWe are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative 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 offer opportunities to engage in social responsibility. 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. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact . To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. 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