Provide quality oversight and guidance for software development, verification, validation, cybersecurity, risk management, and product release activities.
Review and approve software lifecycle deliverables, including requirements, design documentation, traceability records, risk management documentation, verification and validation documentation, cybersecurity documentation, and software change records.
Lead resolution of complex software quality, compliance, and risk management challenges using a risk-based approach.
Influence key product development decisions by applying software quality engineering principles, regulatory expectations, and practical understanding of product risk.
Facilitate quality alignment across Software Development, Product Security, Regulatory Affairs, Product Management, and Program Management functions.
Drive consistency and improvements in software quality processes, tools, templates, and practices across product teams.
Lead or support software risk management activities throughout the product lifecycle.
Support complaint investigations, CAPA activities, audit observations, software nonconformances, and corrective action initiatives.
Provide quality guidance for cloud-enabled, cybersecurity-related, AI-enabled, and data-driven software solutions, as applicable.
Assess emerging technologies, development methodologies, and industry trends to identify quality and compliance improvement opportunities.
Develop and promote best practices, guidance materials, and reusable quality frameworks that improve organizational effectiveness.
Mentor and coach Software Quality Engineers and cross-functional stakeholders on software quality processes, regulatory expectations, and risk-based decision making.
Act as a trusted advisor within the Software Quality organization, helping shape future quality capabilities, operating practices, and organizational best practices.
Support internal and external audits and act as a subject matter expert for software quality-related topics.
Identify organizational risks, quality concerns, and process improvement opportunities, escalating as appropriate.
Contribute to strategic initiatives that strengthen software quality capabilities across the organization.
Support other areas of the Quality System and perform additional tasks as defined by management.
All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.
Preferred Education
Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical or related discipline
Job Requirements
8+ years of experience in software quality engineering, software development, systems engineering, or a related discipline within a regulated industry.
Working knowledge of applicable regulations and standards, including IEC 62304, ISO 13485, QMSR, FDA regulations, and software risk management practices.
Strong understanding of software verification, validation, risk management, cybersecurity, and quality system requirements.
Experience supporting regulated software products, including Software as a Medical Device (SaMD), cloud-based software solutions, or complex software-enabled systems.
Demonstrated ability to influence technical and business decisions without direct authority.
Experience leading complex cross-functional initiatives involving multiple stakeholders.
Experience mentoring engineers or cross-functional partners on software quality practices and regulatory expectations.
Strong analytical, problem-solving, and decision-making skills.
Excellent verbal and written communication skills with the ability to communicate effectively across technical and non-technical audiences.
Experience supporting internal and external regulatory inspections and audits preferred.
Quality and/or Regulatory Certifications (ASQ, AAMI, RAPS, etc.) preferred.
Occasional travel may be required.
Willingness to work in shifts to support the US region (No night shift required).
We 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 accommodations@illumina.com. 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. This role is not eligible for visa sponsorship.
