Staff Software Quality Engineer

illumina

Location: Cambridge
Salary:
Closing Date: 02 April 2020
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WORK PERMIT:
All applicants must be based in the UK and confirm that they are able to prove their eligibility to work in the UK.

Job Description

Support our software developers as they adopt ISO 13485 and EU IVD regulations


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. Youll be providing quality assurance guidance and support to a highly motivated team of software and test engineers at Illuminas clinical laboratories to ensure the software we develop meets our, our customer and regulatory needs.


You will also support the maintenance and improvement of the quality management system for software 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 software 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.


Youll join a culture fueled 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 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 software development and testing activities
Support 3rd party audits
Provide ongoing software quality engineering support throughout the software development life cycle
Provide support to development functions for validation planning and transfer activities
Assist teams in determining verification and validation needs and requirements
Provide support for software development projects by review/approval of software deliverables: e.g. Software Development Plans, Validation Plans, User Requirements, Software Architectural and Design Documents, Risk Management Documents, Test Protocols, Requirement Traceability Matrices, and Summary Reports
Provide review and approval of software related change orders and DHF revisions
Ensure successful transfer of software from development into service and ongoing support
Participate in software the risk management process throughout the entire software lifecycle
Provide quality assurance support to software related CAPAs
Identify and make recommendations for improvements to the Software Development process
Assist in the development and delivery of training to employees on principles of software validation, software risk management, and quality tools.
Responsible for escalating potential risks to management


Preferred background, skills and experience:


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, IEC62304, ISO14971, GAMP5
Working knowledge of Software Development Life Cycle Models
Working knowledge of Software Configuration Management (SCM)
Experience with software verification and validation
Experience with the application or risk management tools
Understanding of software development, inspection, and testing
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 to drive compliance under minimal supervision
Adaptable to fast-paced, dynamic work environment with shifting demands


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