Senior Quality Engineer

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.

Why Us

Illumina are a global leader in genomics –an industry at the intersection of biology and technology. At the most fundamental level, we enable our customers to read and understand genetic variations. We strive to make our solutions increasingly simple, more accessible, and always reliable. As a result, discoveries that were unimaginable even a few years ago are now becoming routine and are making their way into patient treatment. Over the last few years, Illumina has experienced rapid expansion and this Quality Engineer role is supporting our continued growth plans.

Why You

To be successful as our Quality Engineer you will apply quality regulations and standards and establishing and/or maintaining quality systems. You will have strong analytical, problem solving and organizing skills. You will have excellent attention to detail, be well organized and able to work independently as well as working collaboratively as part of the team.

You will thrive in a fast-paced environment and enjoying building relationships with stakeholders within Illumina’s local, regional and global locations.

Like you, we know the importance of your role and offer you a collaborative and supportive environment in which you are actively encouraged to continually develop your own skills and knowledge.

Responsibilities:

• Models Quality culture to the site as part of the Manufacturing Operations Quality team.
• Provide quality support throughout the product life cycle, including quality control, batch record review and other activities as needed.
• Ensures adequacy & completeness of manufacturing and quality records.
• Support the development and execution of actions to close gaps in an efficient, technical, and compliant manner.
• Proactive approach to structured & practical problem solving.
• Participate in investigations to identify problem cause and identification of risks, recommendations, and outcomes
• Apply experience and knowledge of regulations and standards (including ISO 13485:2016) to manage risks and guide actions independently
• Support the development and ongoing monitoring of Key Performance Indicators from a variety of data sources
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.

Requirements:

• Limited applied experience in a quality assurance regulated environment necessary.
• Some experience working with quality management systems including ISO 13485:2016 & in-vitro medical device environment preferred
• Strong communication, facilitation, planning, problem-solving, and organizational skills appropriate to experience level.
• Demonstrated ability or aptitude to learn how to manage and lead change
• Analytical, problem solving and organizing skills
• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact preferred.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands
• Excellent attention to detail, well organized and able to work independently and as a team.

Preferred Background

• Typically requires a Bachelor’s degree; or equivalent work experience
• You are fluent in English;