Senior Software QA Engineer (Embedded, Real Time, Medical)

Recruiter
We Are SSG
Location
Stratford-upon-Avon
Salary
Competitive
Posted
05 Sep 2017
Closes
03 Oct 2017
Contract Type
Permanent

Senior Software QA Engineer (Embedded, Real Time, Medical)

Warwickshire

GBPNeg excellent + benefits

This is a fantastic opportunity to join a fast growing, innovative, high technology medical devices company, developing an advanced system for use both in the home and in medical centres that will significantly improve the quality of life of the patients involved. The product is unique and set to make a significant impact on a multi-billion dollar global market.

The Senior Software QA Engineer is to be the primary contact for any software related Quality Assurance activities ensuring that the 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 mananagement

o Review and approval of software protocols and reports

o Timely verification of sfotware 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
  • To work with Software Development Team, Engineering, Risk Management and other functions in delivering effective solutions.
  • Deputise for the Quality Manager
  • 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

Excellent communication, influencing and collaboration skills

Flexible approach