Senior Software Quality Engineer

About this role

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Skills you'll use

What you'll do

• 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.

Who can apply

• 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

About Illumina

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