Software Quality Engineer

Software Validation Quality Engineer

Location: Galway

Industry: Medical Devices

Area : Quality Software Validation

Must have GMP, Medical Device or Pharmaceutical industry experience.

Job Overview

We are seeking an experienced Software Validation Quality Engineer

to join a leading medical device organisation in Galway. The successful candidate will have a strong background in software validation and quality assurance within a regulated medical device environment.

assuring compliance with validation and software applications, equipment and processes, ensuring compliance with applicable regulatory requirements and company quality standards.

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 collaborationto staff across various functions on software
• validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment,systems and processes.
• Provides software validation/compliance/part 11 training and collaboration in accordance with BSC policies and SOPs.
• Participates in Validation project teams and assists in determining project schedules.
• Works with teams and other departments across the plant to ensure project adherence.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, for resolving quality issues and for Continuous Improvement.

Education & Experience:

• Level 8 Hons Bachelor Degree in Software Engineering, Quality or relevant discipline.
• Minimum 3years experience in a similar role.
• Requires expanded conceptual and technical and/or functional knowledge in own job function
• Broadens capabilities in applying concepts in job function
• Requires technical and/or functional knowledge or the ability to learn for the following:
• Languages: (C#, C++, Java, VB.Net, Python, etc.).
• Database (SQL).
• Power Apps: (Power BI, Power Automate etc).
• Artificial Intelligence Applications.

For more details please contact Gary Keane

[email protected]

086-1030418