Software Assurance Specialist
Our client in Dublin are looking to add a Software Assurance Specialist to their growing team.
This role involves working closely with colleagues to support the development, qualification, and commercialization of innovative medical devices and associated software.
Main Purpose and Objective:
As a key member of our team, you will be responsible for providing leadership on quality assurance initiatives across multiple projects.
You will work closely with software development teams on process optimization for efficient generation and maintenance of regulatory deliverables.
Responsibilities:
* Provide quality leadership for new product introductions and sustaining product development.
* Develop test plans based upon the product requirements.
* Collaborate with cross-functional teams on design controls related activities.
Qualifications
,
You have a bachelor's degree or higher in a related field. You should have at least 3 years experience working in regulated environments. In addition, you must possess excellent technical skills as well as strong communication skills. Knowledge of IEC 62304 is required while ISO13485 certification would be advantageous. A good understanding MDR requirements is also essential.