The Project Quality Engineer role at eg technology involves a pivotal role in compliance of our projects with our business management system, ISO 13485 and applicable legislation, standards and regulations. Project Quality Engineering responsibilities include project work, including documentation of specifications, testing to meet agreed specifications, risk management and managing the transfer to manufacture of client’s projects. The role also comprises internal control, monitoring and supporting the continued improvement of the business management system.
There will be significant contact with:
- Our clients during the course of the documentation, testing and technical file creation in projects.
- Manufacturing partners, suppliers and clients during the transfer to manufacture phases.
Internal communications are also key in this role, and include project trend reporting, internal audits and continuous improvement of the business management systems and project control processes.
Conduct verification test planning , execution and reporting using the Requirement Management System.
To monitor project trends and support control of project budgets and timescales including documentation of specifications, testing to meet agreed specifications. Support risk management activities and transfer to manufacture of client’s projects. Internal control with monitoring to support the continued improvement of the business management system.
Ideal candidate requirements:
A logical thinker to manage the ISO 13485 compliance and monitor project trends and support control of project budgets, with a good honours degree in either a technical/engineering/scientific/medical device regulatory or equivalent who can demonstrate:
- A good understanding and experience of working to industry standards in particular to ISO 13485 or ISO 9001.
- A basic understanding of mechanical, electronics and software engineering.
- Experience in creating quality plans, managing project requirement specifications, test plans and records and reports.
- Experienced in conducting, verification planning, testing and reporting with the generation of appropriate documentation, as part of project deliverable.
- Experience in project progress analytics, trend reporting and problem investigation and resolution.
- Experience in compliance to current legislation industry and harmonized standards Ideally MDR and or IVDR including Risk Management.
- Experienced in planning audit schedules and conducting internal and supplier audits and can demonstrate formal auditing training.
- Excellent communication and personal interaction skills.
Please visit our Careers section to find out more about eg technology, career development of our staff, the benefits we offer and testimonies of why it is great working with us. Salary will be dependent upon individual candidate’s expertise and experience. Interviews can commence at the earliest convenience.
Please email a covering letter explaining why you would like to work for eg technology, a CV and any supporting information. Your application will be acknowledged through egtechnology-factorial-hr.