Senior Software Quality Engineer
Role Overview
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.
Full Job Posting
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)
Qualifications
- Bachelor’s degree in Computer Science, Software Engineering, Bio-Informatics, Biomedical or related discipline
- 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)
About Illumina
Global leader in DNA sequencing and genomic technologies.
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