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

In this Design Quality Engineer role, you will provide support and design quality leadership to one or more product management teams. You will be expected to lead, assess, evaluate, and support implementation of design changes driven by product risk management, post-market surveillance, component end of life, complaints, and other internal or market driven data. The person in this role is expected to work with product development and manufacturing to improve product quality, reliability, and process capability. You will assist the teams with risk assessments, statistical data analysis, test plan development and protocol writing. You will ensure the proper verification and validation of proposed design changes and documentation of results in conformance to FDA and ISO 13485 standards.

All About You

Responsibilities:

• Change management activities for on-market products

• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
• Guide impact assessments for design, process, and risk control activities as required
• Review engineering reports for accuracy and presence of sufficient data to support changes
• Review and approve all required change deliverables
• Risk Management activities

• Perform Product Risk Management File updates and reviews, as required
• Facilitate Risk Assessments on new risks as required
• Provide feedback into new product development and design changes as required
• Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change requests
• Root Cause Analysis activities for on-market products

• Collaborate with teams to apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving product quality issues
• Ensure root cause mitigation was correctly implemented and documented to prevent reoccurrence
• Provide management with status updates on assigned responsibilities and goals- escalating issues and proposing solutions as necessary.
• Take initiative to identify and implement improvements to the Illumina quality system.

• Identify areas and opportunities to improve quality system processes
• Act as technical liaison, as needed, between platform management, product development, manufacturing, external manufacturers & suppliers
• Other activities as assigned

Requirements:

• Experience working in a regulated environment; direct experience working in consumables or reagents development, quality engineering and/or manufacturing desired
• Experience in consumables, assay development, enzyme manufacturing development, library preparation is preferred
• Knowledge of statistics and capability in one or more data analysis tools (JMP, R, Minitab, Tableau, SAS, etc.) is desired
• Practical experience in design controls, risk management, process controls, change management, or post market surveillance desired
• Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, IVDD, CLSI) desired
• Experience with 8D, 6M, fault tree analysis and other failure investigation tools and techniques desired
• Highly effective communication, facilitation, coaching, negotiation and influencing skills
• Adaptable to fast-paced, dynamic work environment with shifting demands

Education:

• A degree in biochemistry, chemistry, molecular biology, or related discipline is required
• Typically requires a minimum of 4 years of related experience with a Bachelor\'s degree; Master\'s or PhD degree preferred. PhD candidates with no industry experience will be considered
• Graduate degree preferred

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

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