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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:
We are seeking a Senior Software Quality Engineer to lead and support quality and compliance activities for Non-Product Software used in support of the Quality Management System (QMS) and Software used in the manufacture process of Illumina’s products.
The Senior Software Quality Engineer ensures the software and systems are verified, validated, maintained, and compliant with applicable regulatory requirements (21CFR820, 21CFR11), International Standards (ISO 13485), standards/guidance (TR80002-2, CSA, General Principles of Software Validation), and company procedures.
Tasks and Responsibilities:
- Review and approve Software Validation deliverables including but not limited to URS, FS, CS, Risk Assessments, Validation Plans, Test Protocols, Reports, change control, etc. to ensure compliance with regulatory requirements.
- Lead Software assessments, classification and categorization.
- Ensure validation activities for Non-Product Software follow applicable regulations (e.g., 21CFR820 and 21CFR11) identifying areas and opportunities to improve.
- Lead software risk management activities for non-product software (NPSW), including software used in support of manufacturing processes (Camstar, LIMS, etc.) and Quality System Software (SAP, ETQ, etc.)
- Develop and conduct training on Software compliance to software developers, Validation engineers, Software testers and other stakeholders within the organization
- Provide guidance on Software Life Cycle process documentation, data integrity, and electronic records/electronic signatures
- Support Data Management, Data Modeling and Supplier Management activities, when required
- Participate in strategic/technical discussions and risk-based decision making
- Collaborate with key stakeholders to properly assess software criticality and complexity.
- Support the change control process for validated systems by performing impact assessments to determine revalidation needs.
- Provide support and guidance with new technologies development (e.g., AI/ML, Cybersecurity, Cloud, etc.) as it relates to software systems and tools
- Support and facilitate internal and external audits related to non-product software domain.
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, Bio-Informatics, Biomedical or related discipline
Job Requirements:
- 5+ years’ experience in (software) quality engineering or related role in a medical device / regulated industry.
- Working experience with relevant industry standards and regulations preferred (eg ISO 13485, 21 CFR)
- Able to deliver quality output under some supervision and with general direction
- Ability to operate flexibly in a fast-paced environment
- Partners with other functions (Software Testing, System Validation, Business Owners, etc.) to drive a culture of Quality
- Works to identify, correct, and prevent obstacles in assurance of non-product software quality
- Good interpersonal, verbal and written communication skills
- Apply Quality Engineering principles (structured development process, risk management, etc.) effectively
- Quality and/or Regulatory Certifications (ASQ, AAMI, etc.) preferred
- Occasional travel may be required
- Working knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices
- 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.
