Quality Engineer 1 - Sterilization Validation (Medtech)

Location: Galway, County Galway, Ireland

Salary: €41,600–€62,400 per year, determined by experience, skills, and qualifications.

Company

hirify.global develops healthcare technologies focused on alleviating pain, restoring health, and extending life.

What you will do

• Support routine sterility assurance activities, including GMP compliance, standards compliance, cleanroom risk assessments, limits reviews, dose audits, cycle requalification, and supplier change control.
• Support sterilization assurance for new products and changes while partnering with manufacturing and design sites.
• Participate in root cause investigations, continuous improvement, and corrective action implementation.
• Support cross-functional teams in developing protocols and evaluating products or product changes against regulatory standards.
• Deliver assigned projects, perform technical calculations and record keeping, and support internal and external audits and submission preparation.
• Review systems and processes for optimization and troubleshooting while following site safety and GMP procedures.

Requirements

• Minimum Level 7 degree in a relevant technical discipline, such as science or engineering.
• Strong understanding of GMP and required documentation.
• Ability to work proactively and effectively both independently and in cross-functional teams.
• Good communication skills and a collaborative approach.

Nice to have

• 1–2 years of experience in sterilization validation or microbiology.

Culture & Benefits

• Purpose-driven work supporting healthcare technologies and patient outcomes.
• Full-time employment with a competitive benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Opportunities to work with manufacturing, design, and cross-functional teams.