Software Validation Quality Engineer - Medical Devices

CREGG; Galway; On-site; Confidential; Full time

Job summary

CREGG in Galway is seeking an experienced Software Validation Quality Engineer to join our medical devices team. You will apply a strong background in software validation and QA within a regulated environment, ensuring compliance with validation activities, software, equipment and processes.

Collaborate with cross‑functional teams to review Master Validation Plans, Validation Protocols, URS, FDS and software design specs, and ensure deviations are controlled and documented to GMP and company

Qualifications

• Level 8 Hons Bachelor Degree in Software Engineering, Quality or relevant discipline.
• Minimum 3 years experience in a similar role.
• Languages: C#, C++, Java, VB.Net, Python, etc.
• Database: SQL.
• Power Apps: Power BI, Power Automate etc.
• Artificial Intelligence Applications.

Responsibilities

• Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
• Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
• Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems.
• Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
• Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
• Provides training and collaboration to staff across various functions on software validation to ensure best practice is maintained.

Skills

C#

C++

Java

VB.Net

Python

SQL

Power BI

Power Automate

AI applications

Education

Level 8 Hons Bachelor Degree in Software Engineering, Quality or relevant discipline

Tools

Power Apps

Job description

CREGG in Galway is seeking an experienced Software Validation Quality Engineer to join our medical devices team. You will apply a strong background in software validation and QA within a regulated environment, ensuring compliance with validation activities, software, equipment and processes.

Collaborate with cross‑functional teams to review Master Validation Plans, Validation Protocols, URS, FDS and software design specs, and ensure deviations are controlled and documented to GMP and company