Job Description

What if the work you did every day could impact the lives of people you know? Or all of humanity? 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:

The Software Quality group is a highly specialized group within Design Quality. The Software Quality Engineer 2 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.

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
• Drive software risk management activities in accordance with industry standards
• Ensure quality and completeness of design history files for software
• Develop and conduct training on software life cycle framework to software developers, testers and other stakeholders within the organization
• Participate in strategic/technical discussions and risk-based decision making
• Ensure SLC processes meet quality and regulatory requirements and identify areas and opportunities to improve quality system processes
• 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

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.

Preferred Education:

• Bachelor\'s degree in Computer Science, Software Engineering, Bio-Informatics, Biomedical or related discipline

Preferred Requirements:

• Working knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices
• 2+ years\' experience in (software) design quality engineering or related role in a medical device / IVD company environment
• Working experience with relevant industry standards (ISO 13485, ISO 14971, IEC 62304)
• 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 (Product Development, Testing, Validation, etc.) to drive a culture of Quality
• Works to identify, correct, and prevent obstacles in assurance of 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, RAPS, AAMI, etc.) (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 , 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.

Additional Information

Career Level

Junior Executive

Qualification

Bachelor\'s Degree, Post Graduate Diploma, Professional Degree, Master\'s Degree

Years of Experience

5 years

Job Type

Full-Time

Job Specializations

,

Company Overview

At Illumina, we\'re making genomics more useful for all, for a better understanding of human health. By shining a brighter light on genomics, together we can harness the power to build a stronger world.
From our earliest startup days, we\'ve always aspired to transform human health. Each new product is designed to empower our community to explore DNA at an entirely new scale, and discover answers to life\'s biggest questions. Like what causes a cancer cell to mutate? What\'s the origin of a puzzling disease? Is it possible to prevent the next outbreak? Or safeguard the world\'s food supply? These challenges inspire us to push the boundaries of what\'s possible, and connect more people to the technology and insights changing the world.
Today we\'re a global leader in genomics-an industry at the intersection of biology and technology. We\'re passionate about helping our customers read and understand genetic variations through our increasingly accessible, simple solutions. The advances our solutions support are triggering a fundamental shift in healthcare and beyond. Medicine will continue to become more preventive and more precise. We will be healthier, longer. And we\'ve only just begun.

Additional Company Information

Registration No.

200310311H

Company Size

501 - 1000 Employees

Average Processing Time

30 days

Industry

BioTechnology/Pharmaceutical/Clinical research

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