Staff Design Quality Engineer

Staff Design Quality Engineer  – UK

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 role is supporting our continued growth plans. This role is based in our EMEA Head Office in Cambridge UK, where you will be a vital part of the Quality team. You will work across EMEA and get involved in extensive truly exciting projects involving improving human health.

Why You

Illumina Laboratory Services are at the forefront of bringing whole genome sequencing into healthcare, helping change lives by driving adoption of sequencing in the diagnosis of rare disease and emerging cancer applications. Your new colleagues are all deeply passionate about what they do, knowing that our work has the power to improve lives 

The role

As Staff Quality Engineer for Software Development, you will act as SME lead. You will ensure product software and software development process conformance to applicable safety and quality system regulations and standards (e.g. IEC 62304, ISO 13485). You will be responsible for guiding teams in execution of Software Life Cycle activities with focus on product development quality planning and risk management to positively impact the safety and efficacy of products.  You will facilitate teams in identifying, documenting, assessing, correcting and preventing quality issues using risk analysis, root cause analysis tools, from initial product concept through transfer to sustaining.

This is an exciting opportunity to be part of Illumina’s continued growth. 

Responsibilities will include, but are not limited to

  • Implement and improve software development quality system processes in accordance with safety and quality system regulations and standards.
  • Support cross functional teams to ensure software is developed and maintained in accordance with regulations and internal requirements and procedures.
  • Resolve complex issues in creative and effective ways using professional Quality Management concepts in line with company objectives.
  • Establish and implement quality assurance best practices in the areas of software product development, risk management, and ongoing change controls.
  • Facilitate identification of product risks and risk mitigations for software development and change controls.
  • Partner with other functions to drive a culture of Quality, understanding of Costs of Poor Quality and Critical to Quality attributes.
  • Ensure compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
  • Review and approve change control documentation.
  • Participate in non-conformance investigations and ensure CAPA findings, risks, recommendations and outcomes are appropriate and are clearly documented and communicated.
  • Become familiar with the applicable technology to participate in technical discussions and risk-based decision-making.
  • Trend, analyze, and report on quality data in order to improve product and process.
  • Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
  • Other such duties that may be determined by Management.

Listed responsibilities are essential, but not an exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Preferred background, skills and experience  

  • Working knowledge of design control principles and software development life cycle models
  • Experience applying quality regulations and standards (IEC 62304, ISO 13485) and establishing quality systems
  • Experience in a regulated environment, ideally in vitro diagnostics / medical device or other regulated industry
  • Excellent interpersonal, verbal and written communication skills
  • Excellent attention to detail, well organized, able to work independently and with a team and provide SME leadership
  • Ability to operate flexibly in fast-paced environment

What can you expect:

With Illumina you can expect a highly competitive salary accompanied by a market leading benefits package.  You will be part of the global leader in the Sequencing industry where you will find robust growth opportunities and career development within Illumina. 

Our team members are bright, energetic, and dedicated—they are the driving force behind our innovation and impact. To attract the best and brightest, we offer a competitive employee benefits program. We view it as a smart investment in our people, one that recognizes the tremendous value they bring to our business every day. At Illumina, we push boundaries. We think beyond the conventional. We dream big. With the energy of so many bright and accomplished people, the opportunities are endless.

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