Senior Software Quality Engineer
Location: Limerick, Munster, Ireland
Contract Type: Full-time
About the Role
We are seeking a Senior Software Quality Engineer to join a leading global organisation in the medical technology sector. This role is pivotal in supporting site operations and cross-functional project teams, including new product development, technology transfer, and initiatives aimed at enhancing operational effectiveness.
The position focuses on creating and maintaining quality processes and procedures that support design control, process validation, supplier management, and compliance with international standards. You will act as a subject matter expert for software quality, ensuring deliverables meet customer expectations and regulatory requirements such as 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and EU MDR.
Key Responsibilities
* Develop and maintain strategies to improve software quality, including test coverage and system performance.
* Lead design and functional review processes for software products.
* Collaborate with R&D and Manufacturing teams to drive design improvements and monitor measurable enhancements.
* Ensure compliance with regulatory guidelines and internal policies.
* Represent the Quality function on core teams for new product development and technology transfer.
* Manage software development lifecycle activities including requirements, risk management, verification and validation (V&V).
* Address audit findings and CAPAs related to software.
* Review and approve critical documentation, including product drawings and validation protocols.
* Apply statistical tools for data analysis and root cause identification.
About You
* Degree in Electrical, Mechanical, Software, or Biomedical Engineering (or related technical field).
* Significant experience in software development or lifecycle management, with progressive responsibility in quality engineering.
* Strong knowledge of FDA and ISO standards for medical devices.
* Skilled in design control, risk management, validation planning, and Six Sigma tools.
* Excellent communication skills for written and verbal interactions across teams.
* Ability to manage multiple tasks and lead change management initiatives.
Additional Information
* Full-time position with comprehensive benefits.
* Occasional travel may be required.
* Security clearance and visa sponsorship are not available for this role
Job Types: Full-time, Permanent
Ability to commute/relocate:
* Dooradoyle, Limerick, CO. Limerick: reliably commute or plan to relocate before starting work (required)
Work authorisation:
* Ireland (required)
Work Location: In person