Senior Software Quality Engineer - Limerick - Innovate Skillsource

Description

Skillsource is supporting a global leader in the medical technology sector to hire a Senior Software Quality Engineer for a high‑impact role within a rapidly developing R&D and software innovation environment.

Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.

This position supports the establishment and strengthening of quality systems, software compliance processes, and design‑assurance oversight for new product development and technology transfer initiatives. The role will suit a quality professional experienced in regulated software development, design controls, lifecycle management, and cross‑functional collaboration.

Role Purpose

The Senior Software Quality Engineer will act as a key quality representative supporting project teams engaged in software development, manufacturing transfer, and operational improvement initiatives. A core part of the role involves contributing to and shaping the Quality Management System (QMS) for the site, with emphasis on design control, process validation, supplier oversight, and technology transfer practices.

You will be expected to provide leadership on software quality and regulatory compliance, including computer system validation, risk management, documentation review, and ensuring adherence to global standards throughout the product lifecycle.

Key ResponsibilitiesQuality Engineering Leadership

- Support the development, enhancement, and maintenance of quality strategies, processes, and plans related to software quality, test coverage, system performance, and compliance.
- Provide both strategic and practical support to Quality Engineering activities based on regulatory expectations and industry best practices.
- Represent the Quality function on New Product Development and Technology Transfer Core Teams.

Design Control & Documentation

- Own and facilitate Design Review and Functional Review processes for software‑related products and subsystems.
- Review and approve software‑related documentation, including requirements, specifications, design artefacts, verification/validation protocols, and reports.
- Evaluate software drawings, documentation updates, and change requests to ensure accuracy and compliance.

Regulatory & Standards Compliance

- Ensure all relevant activities comply with applicable regulations and standards including:

- 21 CFR 820 (Quality System Regulation)

- 21 CFR 11 (Electronic Records & Signatures)

- ISO 13485, ISO 14971

- IEC 62304 (Software Lifecycle)

- Other applicable device and regulatory frameworks

- Oversee computer system validation activities and assess compliance with electronic record requirements.

Risk Management

- Lead or contribute to software risk management activities across development, verification, validation, and transfer.
- Apply structured analytical tools (root cause analysis, statistical analysis, reliability principles) to identify issues and support problem resolution.

Cross‑Functional Collaboration

- Work alongside R&D, Manufacturing Engineering, Operations, and Regulatory Affairs to support software design improvements, enhance reliability, and drive measurable product enhancements.
- Manage and coordinate responses to findings from audits, CAPAs, and assessments related to software compliance.

Quality Assurance & Continuous Improvement

- Ensure that internal policies, procedures, and engineering practices align with relevant regulatory guidelines.
- Support remediation of software‑related non‑conformances, audit findings, and CAPA activities.
- Contribute to the evolution of quality processes and culture across the site.

Candidate ProfileEssential Qualifications & Experience

- Bachelors degree in Electrical, Mechanical, Software, Biomedical Engineering, or related technical field.
- Minimum 6–7 years of experience, including 4+ years in software development, software lifecycle management, or software‑related quality roles.
- Strong understanding of design control, validation, statistical sampling, Six Sigma tools, and project management methodologies.
- Experience in applying structured problem‑solving approaches, including root cause analysis, failure mode analysis, and risk assessment.
- Excellent documentation, communication, and presentation skills with an ability to tailor messaging to different audiences.
- Demonstrated ability to manage multiple priorities and drive change through cross‑functional teams.
- Working knowledge of FDA, ISO, and other regulatory frameworks relevant to software‑enabled medical devices.

Desirable Attributes

- Experience supporting software design for complex embedded systems.
- Exposure to technology transfer environments or new product introduction projects.
- Ability to facilitate conflict‑resolution and maintain momentum in technical teams.

Working Model

This is primarily an on‑site role, requiring up to four days per week on site to support collaboration, problem‑solving, and alignment across multidisciplinary engineering teams.

Contract Details

- Type: Full‑time
- Level: Mid‑Senior
- Travel: Occasional
- Security Clearance: Not required
- Visa Sponsorship: Not available

Why Apply?

This role offers the chance to influence the quality and regulatory direction of cutting‑edge medical software products. xlwxzce You will shape quality processes for a growing innovation site, collaborate with high‑calibre technical teams, and contribute to software that supports life‑enhancing medical technologies.

#J-18808-Ljbffr