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 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.

Additional Information

Career Level

Junior Executive

Qualification

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

Job Type

Full-Time

Job Specializations

,

Company Overview

Do you want to make a difference? Illumina\'s mission is to improve human health by unlocking the power of the genome. If that inspires you, let\'s talk. We\'ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.

We\'re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.2 billion in 2015. Our growth isn\'t just revenue, we\'ve been hiring the best and the brightest. Perhaps that\'s why MIT has ranked Illumina near the top of its World\'s Smartest Companies list three years running, including #1 in 2014. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you - imagine the possibilities.

Additional Company Information

Registration No.

200310311H

Company Size

2001 - 5000 Employees

Industry

BioTechnology/Pharmaceutical/Clinical research

Benefits & Others

Dental, Education support, Miscellaneous allowance, Medical, Vision, Regular hours, Mondays - Fridays, Casual (e.g. T-shirts)

Company photos

1/8

Singapore Post