Senior Software Quality Engineer

Senior Software Quality Engineer

Location: County Limerick, Munster, Ireland (Onsite)
Industry: Medical Devices / MedTech
Employment Type: Full-Time

About the Opportunity

A global medical technology organization is seeking a Senior Software Quality Engineer to support software used in regulated medical device products. This role is a key contributor within cross-functional development teams and plays a critical part in ensuring that software meets quality, regulatory, and patient safety expectations throughout the product lifecycle.

You will partner closely with R&D, manufacturing, and quality teams to guide software quality practices from early design through product release and post-market support. This is an excellent opportunity for someone who enjoys both technical problem-solving and regulatory quality work in a highly collaborative engineering environment.

What You'll Do

• Serve as the Software Quality representative on product development and technology transfer teams

• Support new product development and ensure software compliance with regulatory and quality standards

• Participate in design planning, design reviews, and functional reviews

• Guide software lifecycle activities including requirements review, development planning, risk management, and verification & validation

• Ensure compliance with medical device regulations and quality system requirements

• Review and approve software-related documentation, including verification and validation protocols

• Support audit readiness and remediation of audit findings and CAPAs

• Collaborate with R&D and manufacturing to investigate issues and drive design improvements

• Apply statistical analysis and root cause analysis to identify and resolve software quality issues

• Support change control and release processes for software products

• Contribute to continuous improvement of software quality processes and test coverage

Required Qualifications

• Bachelor's degree in Software, Electrical, Biomedical, Mechanical Engineering, or related technical field

• Approximately 5–7 years of relevant experience

• Experience in Software Quality, Software Design Assurance, or software lifecycle management within a regulated environment

• Knowledge of IEC 62304 software lifecycle processes

• Experience working with ISO 13485 and FDA 21 CFR Part 820 design controls

• Experience participating in design reviews, risk management, and verification/validation activities

• Experience supporting audits, CAPAs, or regulatory compliance activities

• Strong written and verbal communication skills

• Ability to collaborate across engineering, quality, and manufacturing teams

Preferred Experience

• Medical device, IVD, or life sciences software

• Risk management (ISO 14971)

• Computer System Validation (CSV) or electronic records compliance (21 CFR Part 11)

• Embedded or application software development environments

• Root cause analysis and statistical methods

Work Environment

This is an onsite role located in County Limerick, Ireland. Candidates must already be authorized to work in Ireland.

Why Apply?

You will join a team focused on improving patient outcomes through safe and reliable medical technology. This role offers exposure to the full product lifecycle, meaningful collaboration with engineering teams, and the opportunity to directly impact product quality and regulatory compliance.