Senior Software Quality Engineer
ROLE: Senior Software Quality Engineer
LOCATION: Birmingham, Midlands
SALARY: £50,000 + share options + bonus + benefits
We are acting on behalf of a very successful and highly innovative medical devices manufacturer in the Birmingham area. This company has created waves on a global scale with their innovation and due to steady growth and success, they now have several positions on offer within their technical team.
This is a fantastic opportunity for a senior software quality engineer looking for a company that will really reward good performance. The purpose of this role will be to review all software-related documentation from a QA perspective. For example, you will be required to review software plans for the development of software, verification, maintenance and management. You will be the primary contact for any software-related quality assurance activities and as such you will have worked with relevant quality standards including ISO 13485 and 21 CFR 820 covering software development lifecycles.
In addition to this you will be expected to:
- Review all software related documents from a QA oversight perspective, e.g. software plans for software development, verification, maintenance and management;
o Review and approval of software protocols and reports;
o 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;
- 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.
- You will have an engineering / software engineering / computer science degree: BSc (Hons) or BEng (Hons);
- You will ideally have worked within life-sciences / pharmaceuticals / medical sectors and more specifically, within PEMS (Programmable Electrical Medical Systems);
- You will possess transferable IT skills including e-QMS (e.g. electronic document management systems);
- Experience of configuring and using dynamic and static analysis tools, as well as software test tools;
- You will have experience of working to the requirements of a Quality Management System compliant with relevant international standards (ISO 13485 / 14971 / 60601 / IEC 62304 / 21 CFR 820 covering the full software product lifecycle);
- You will possess exceptional communication and stakeholder management skills.
This company is headed in a very exciting direction and this could be a seriously career-making role for the right individual. For a confidential chat, please contact Mohsin Patel.