We are delighted to be partnering with an exciting Medical Device company based in Dublin, on a permanent Software QA Engineer position.
This role will be a significant contribution to this company in a pivotal stage of their growth and will focus on supporting quality and compliance activities associated with company software and drive the execution of related objectives.
Responsibilities:
- Participate in cross functional product development and provide practical QA and Design Assurance expertise, in particular related to software design and development, verification and validation, risk management, manufacture and control.
- Drive software quality assurance process optimisation and improvements, as needed, to ensure that all software quality systems remain fit for purpose and satisfy all customer requirements.
- Collaborate with the wider team to ensure that necessary and sufficient QA activities are planned, executed, and recorded.
- Ensure computer system validation (CSV) processes are in place and followed.
- Manage suppliers to support quality assurance of product software and assessment/validation of QMS software.
Requirements:
- Bachelor’s Degree in Engineering, Science or software related field.
- 3+ years’ experience in medical device quality/design assurance role with focus on medical device software (or similar regulated industry such as pharmaceuticals).
- Strong knowledge of the software development lifecycle (i.e. IEC62304).
- Recent regulatory experience including FDA regulations, Medical Device.
- Regulation (MDR) and other applicable national and international regulations and Standards.
