The Software Quality group is a highly specialized group within Design Quality. The Software Quality Engineer provides support to Illumina’s software development teams to ensure that the company’s product software is designed in accordance with Illumina’s policies/ procedures and applicable regulations (e.g. FDA) and ISO standards.
The engineer will implement continuous improvements to the software quality process and provide guidance and support to the development teams.
This is not a software testing position.
Tasks and Responsibilities:
- Provide quality support to new and sustaining product development teams focusing on software life cycle processes within design control. This includes design, verification, validation, risk management, software configuration management and deployment including reviews and approvals
- Participate in the software risk management activities
- Ensure quality and completeness of design history files for software
- Support training efforts on software life cycle framework to software developers, testers and other stakeholders within the organization
- Participate in technical discussions and risk-based decision making
- Provide inputs to continuous improvements initiatives
- Support post market activities related to product software anomalies - Complaint Handling, MDR’s, CAPAs
- Trend, analyze, and report on quality data to improve product and process
- Holds themselves, and individuals accountable to product quality, and accepts critique as motivation to learn and further develop
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
- Bachelor’s degree in Computer Science, Software Engineering, Bio-Informatics, Biomedical or related discipline
- Understanding of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices
- 2 to 8 years’ experience in software engineering, quality engineering or related role in a medical device / IVD company environment
- Familiarity with relevant industry standards (ISO 13485, ISO 14971, IEC 62304)
- Able to deliver quality outputs under general supervision/direction
- Ability to operate flexibly in fast paced environment
- Perform and participate effectively in team environment
- Works to achieve goals in spite of challenge, and actively works to overcome obstacles without sacrificing quality
- Effectively utilize Quality Engineering tools
- Experience with software development in a programmer, tester, project management or related capacity
- Experience with product development and quality engineering activities
- Good interpersonal, verbal and written communication skills
- Quality and/or Regulatory Certifications
- Experience working in Medical Device or Biotechnology company preferred
- Occasional travel may be required
Illumina believes that everyone has the ability to make an impact, and 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.