What the Team does;
Illumina Laboratory Services, the team who completed the DNA sequencing for the 100,000 Genomes Project, are now entering the next phase to deliver whole-genome sequencing into routine healthcare in partnership with Genomics England and the NHS. A critical aspect of this is ensuring the pipeline we develop meets both evolving customer and regulatory needs.
Would you like the opportunity of being a part of a multidisciplinary group that delivers software solutions to enable cutting-edge sequencing operations that make a difference to peoples’ lives?
What the role is;
Support our assay and software developers as they adopt ISO 13485 and EU IVD regulations
As a Quality Engineer you’ll be providing quality assurance guidance and support to a highly motivated team of assay and software engineers at Illumina’s clinical laboratories to ensure the product we develop meets our customer and regulatory needs.
You will also support the maintenance and improvement of the quality management system for design control in the Illumina Laboratory Services medical laboratory group.
Ideally you will be an adaptive person with great interpersonal and organisational skills, along with a solid understanding of the application of appropriate standards to product development (e.g. 13485/14971/IEC 62304/IVD directive/regulations).
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.
You’ll join a culture fuelled by innovation, collaboration and openness. 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.
Responsibilities will include:
- Provide ongoing quality engineering support to development teams in the areas of design control, risk management, design verification and validation, and design transfer to the laboratory
- Review/approval of design control deliverables: e.g. development plans, user needs and design inputs, specifications and design documents, risk management documents, verification and validation plans, test protocols and reports, requirement traceability matrices, and summary reports
- Assist teams in determining verification and validation needs and requirements
- Provide review and approval of design related change orders and design history file updates
- Coordinate design issue resolution using a risk-based approach and escalate potential risks to management
- Assist in the development and delivery of training to employees on principles of design control, risk management, and quality tools.
- Identify and make recommendations for improvements to design control and risk management processes
- Provide interpretation and guidance on quality standards, regulations and directives and develop procedures to ensure compliance
- Liaise with colleagues across sites (California, Cambridge) to ensure a unified approach is taken to quality system processes
- Work as part of a wider quality assurance team to ensure the integration of quality system processes for development and testing activities
- Provide quality assurance support to design related CAPAs
- Support 3rd party audits
What you need for the role;
- Experience in a regulated environment, ideally in vitro diagnostics/medical device or other regulated industry
- Experience and working knowledge of applicable regulations and standards: e.g. 21CFR 820, 21CFR Part 11, ISO 13485, IEC 62304, ISO 14971, GAMP5
- Working knowledge of design control principles and/or software development life cycle models
- Experience with design verification and validation
- Experience with the application or risk management tools
- Excellent attention to detail, strong organization skills, and ability to work independently and in teams
- Excellent interpersonal, verbal and written communication skills
- Ability to operate flexibly in fast-paced environment
- Able to deliver and drive compliance under minimal supervision
- Adaptable to fast-paced, dynamic work environment with shifting demands
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunities 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.
What can you expect;
•A highly competitive salary
•Market leading benefits package
•Being part of the global leader in the Sequencing industry
•Robust growth opportunities within Illumina