Illumina Singapore Pte Ltd

Staff Software Quality Engineer

Illumina Singapore Pte Ltd Date Posted: 10-Nov-2017

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Job Description

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. Life at Illumina is about working with teammates who 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. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.


All About You

 
The Staff Software Quality (SQA) 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 and procedures. Illumina’s processes and procedures are structured to meet the requirements for diagnostic medical devices (IVDs), requirements for products to be deployed in laboratory developed tests (LDTs), research use only (RUO)  products, as well as diverse other applied genomic (e.g. forensics, agriculture).
 
Required Skills / Levels:

  • Quality Acumen
    • Wide-ranging experience.
    • Use of professional concepts and company objectives to resolve complex issues.
    • Development of Quality Plans with specific subject matter expertise.
    • Establishes SQA best practices across all SW functions.
  • Job Complexity
    • Works on complex issues where analysis of situations or data requires an in-depth evaluation.
    • Exercises judgment in electing methods techniques and evaluation criteria.
    • Networks with key contracts outside of SQA area.
    • Identifies, defines and manages multiple projects of medium scale complexity.
    • Able to identify express and communicate risks, provide recommendation for mitigations on project level
    • Drive measures of accountability through process a motivation (lead by example).

  • Influence and Impact
    • Influences individuals and departments to achieve quality products
    • Influences decision at critical points in time with a development life cycle
    • Facilitates agreements, persistent with different approaches to meet quality expectations
    • Recognize and communicate issues that have global impact at Sr. Management Level, offering solutions
    • Leverages strong technical subject matter expertise

  • Teamwork and Relationships
    • Encourages collaborative team environment as quality leader.
    • Encourages receptivity to ideas and appreciates alternative backgrounds.
    • Fosters relationships within the internal software development community to improve understanding of their needs and expectations.

  •   Communication
    • Facilitates conversations to improve understanding amongst the team’s perspectives and viewpoints.
    • Anticipates issues and forms possible solutions for communication.
    • Proactively communicates and escalates unresolved issues
    • Exceptional verbal and written communications, clear, precise and fact driven
    • Partners with others to drive a culture of quality and understanding of costs of poor quality.

 
Education / Software QA experience:

  • Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical or related discipline. Graduate degree preferred
  • 8 years’ experience in (software) quality engineering role in a medical device / IVD company environment.
  • Desired Quality/Regulatory certifications (CSQE, CQE, CQM, RAC)
  • ASQ certification desired
  • Expert knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices Design Controls, Risk Management, Verification and Validation
  • A solid understanding of the application of regulations and standards (21CFR 820, IVDD/IVDR, ISO 13485, ISO 14971, IEC62304).
  • Experience with Clinical Trials/Evaluations, GxP, Auditing and CROs is a plus.
  • Experience with post market activities (complaint handling / failure investigations) relative to software
  • Comprehend software technical reports and specification documents.
  • Occasional travel may be required.

Preferred:

  • Hands-on experience with Next Generation Sequencing consumables and chemistry.
  • Hands-on experience with Software used in Next Generation Sequencing products

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.
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. Life at Illumina is about working with teammates who 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. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.


All About You

 
The Staff Software Quality (SQA) 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 and procedures. Illumina’s processes and procedures are structured to meet the requirements for diagnostic medical devices (IVDs), requirements for products to be deployed in laboratory developed tests (LDTs), research use only (RUO)  products, as well as diverse other applied genomic (e.g. forensics, agriculture).
 
Required Skills / Levels:

  • Quality Acumen
    • Wide-ranging experience.
    • Use of professional concepts and company objectives to resolve complex issues.
    • Development of Quality Plans with specific subject matter expertise.
    • Establishes SQA best practices across all SW functions.
  • Job Complexity
    • Works on complex issues where analysis of situations or data requires an in-depth evaluation.
    • Exercises judgment in electing methods techniques and evaluation criteria.
    • Networks with key contracts outside of SQA area.
    • Identifies, defines and manages multiple projects of medium scale complexity.
    • Able to identify express and communicate risks, provide recommendation for mitigations on project level
    • Drive measures of accountability through process a motivation (lead by example).

  • Influence and Impact
    • Influences individuals and departments to achieve quality products
    • Influences decision at critical points in time with a development life cycle
    • Facilitates agreements, persistent with different approaches to meet quality expectations
    • Recognize and communicate issues that have global impact at Sr. Management Level, offering solutions
    • Leverages strong technical subject matter expertise

  • Teamwork and Relationships
    • Encourages collaborative team environment as quality leader.
    • Encourages receptivity to ideas and appreciates alternative backgrounds.
    • Fosters relationships within the internal software development community to improve understanding of their needs and expectations.

  •   Communication
    • Facilitates conversations to improve understanding amongst the team’s perspectives and viewpoints.
    • Anticipates issues and forms possible solutions for communication.
    • Proactively communicates and escalates unresolved issues
    • Exceptional verbal and written communications, clear, precise and fact driven
    • Partners with others to drive a culture of quality and understanding of costs of poor quality.

 
Education / Software QA experience:

  • Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical or related discipline. Graduate degree preferred
  • 8 years’ experience in (software) quality engineering role in a medical device / IVD company environment.
  • Desired Quality/Regulatory certifications (CSQE, CQE, CQM, RAC)
  • ASQ certification desired
  • Expert knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices Design Controls, Risk Management, Verification and Validation
  • A solid understanding of the application of regulations and standards (21CFR 820, IVDD/IVDR, ISO 13485, ISO 14971, IEC62304).
  • Experience with Clinical Trials/Evaluations, GxP, Auditing and CROs is a plus.
  • Experience with post market activities (complaint handling / failure investigations) relative to software
  • Comprehend software technical reports and specification documents.
  • Occasional travel may be required.

Preferred:

  • Hands-on experience with Next Generation Sequencing consumables and chemistry.
  • Hands-on experience with Software used in Next Generation Sequencing products

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.

Company Overview

Illumina Singapore Pte Ltd
Illumina Singapore Pte Ltd
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 $2.4 billion in 2016. 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 each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven en