Planet Pharma

Senior Software Quality Engineer

Limerick, Limerick xxx IE

Posted: 02/16/2026 2026-02-16 2026-03-19 Employment Type: Direct Hire/Perm Job Category: Engineering Job Number: 625676 Is job remote?: No Country: Ireland

Job Description

An established global healthcare technology organisation is expanding its engineering group and now seeks a Senior Software Quality Engineer to join its on?site team. This role sits within a high?impact function supporting new product development, tech transfer and continuous improvement across a broad portfolio of regulated medical technologies.

You’ll act as a key quality partner to cross?functional engineering teams, ensuring software deliverables meet customer expectations and comply with all relevant regulatory and quality standards. This position is ideal for someone who enjoys influencing design, shaping validation strategy and acting as an emerging subject matter expert in software quality within Life Sciences.

What you’ll do

• Lead quality assurance activities for software within new product development, manufacturing transfer and improvement initiatives.
• Own and facilitate Design Review and Functional Review processes.
• Guide software verification, validation planning, and design?related quality activities, including risk management and change control.
• Support statistical sampling, reliability assessments and root?cause investigations using structured problem?solving tools.
• Review and approve software?related documentation, including drawings, protocols and reports.
• Partner with R&D and Manufacturing to drive design improvements and monitor measurable quality outcomes.
• Support remediation of software?related audit findings and CAPAs.
• Ensure compliance with applicable regulatory frameworks including FDA, ISO and EU requirements.

What you bring

• 5+ years’ experience in Software Quality Assurance/Control within Life Sciences; medical device experience strongly preferred.
• Degree in Electrical, Mechanical, Software or Biomedical Engineering.
• Hands-on experience with design review, functional review, reliability concepts, validation planning and statistical sampling.
• Proven ability to manage multiple priorities and lead quality activities within complex engineering projects.
• Strong communication skills, with the ability to write clearly and influence across teams.
• Experience applying systematic analysis tools for root cause, failure analysis and risk assessment.
• Working knowledge of relevant regulatory standards (e.g., FDA 21 CFR 820, ISO frameworks).

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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