Senior Software Quality Engineer

Illumina; Bengaluru; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

Illumina is looking for a Senior Software Quality Engineer in Bengaluru, India, to lead quality and compliance efforts for Non-Product Software impacting their Quality Management System. This role requires an extensive understanding of software validation and risk management in the medical device industry.

The ideal candidate will have over 5 years of experience in software quality engineering, excellent communication skills, and a Bachelor's degree in a relevant field. Competitive benefits and shift work may be required to support US operations.

Qualifications

• 5+ years of experience in software quality engineering or related role in a medical device / regulated industry.
• Working experience with relevant industry standards and regulations (e.g., ISO13485, 21 CFR).
• Quality and/or regulatory certifications (ASQ, AAMI, etc.) preferred.

Responsibilities

• Review and approve Software Validation deliverables for compliance.
• Lead software assessments and risk management activities.
• Collaborate with stakeholders to assess software criticality.
• Support data management and internal audits.

Skills

Software Quality Engineering

Risk Management

Regulatory Compliance

Quality Assurance

Interpersonal Communication

Education

Bachelor’s degree in Computer Science or related discipline

Job description

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 (ISO13485), 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.

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 (e.g., ISO13485, 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.
• Willingness to work in shifts to support the US region (no night shift required).

Legal and Equal Opportunity Statement

Illumina is 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.

This role is not eligible for visa sponsorship.