Senior Software Quality Engineer

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Senior Software Quality Engineer

My client is a pioneering medical devices company, who have developed advanced haemodialysis systems for use in the home and clinic. They are currently seeking an experienced Senior Software Quality Engineer be based at their Alcester location on a Permanent basis.

Job Description

Job Title Senior Software Quality Engineer

Location Alcester

To be the primary contact of the Company for any software related Quality Assurance activities. The Senior Software QA Engineer will ensure that software development lifecycle satisfies the requirements of the relevant quality standards (including ISO 13485 and 21 CFR 820).

Key Responsibilities

* Review all software related documents from a QA oversight perspective, e.g. software plans for software development, verification, maintenance and management
* Review and approval of software protocols and reports
* Timely verification of software releases
* Support the management of QA software tools, e.g. e-QMS.
* Lead software qualification for QA software tools: Design and implement software verification tests and test procedures
* QA Lead for development of software related QMS procedures

Other Responsibilities

* Represent QA in design reviews and QA Lead for software design control
* To provide recommendations regarding improvements to the QMS and software development lifecycle and testing practices within the company
* Review/approval of software change requests
* QA Closing of Quality issues
* QA review of QMS documents

Requirements/Qualifications

* Educated to degree level, with a related Batchelor's degree in an Engineering/Software Engineering/Computer Science or Science discipline
* Experience in working with PEMS (Programmable Electrical Medical Systems) or equivalent high-integrity embedded systems, e.g. complex devices requiring multidisciplinary development effort (mechanical engineering, software, electronics, system integration, pneumatics, fluid mechanics etc.)
* Transferable IT skills including e-QMS (e.g. electronic document management system, requirements management system)
* Experience of configuring and using dynamic and static analysis tools, as well as software system test tools
* Experience of working within a QMS and software lifecycle process under standards such as ISO 13485, ISO 14971, ISO 60601, IEC 62304 and 21 CFR 820

If you're interested in this opportunity then please contact Zara Riley on 02392 458018 or at .

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Key Consultant

Zara Riley

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Meet Zara, a junior consultant in our Manufacturing and Technologies recruitment team.