Senior Quality Engineer - Process Validation (Medical Devices)

Location: Athlone, County Westmeath, Ireland

Salary: €64,640–€96,960 per year

Company

hirify.global develops healthcare technologies intended to alleviate pain, restore health, and extend life, operating across more than 150 countries.

What you will do

• Lead end-to-end validation activities for processes, equipment, inspections, and products throughout the product lifecycle.
• Develop process validation strategies and provide technical direction for equipment qualification and validation.
• Support design and validation builds, production control, product evaluation, reliability, and research and development activities.
• Author qualification and validation plans and reports, including statistical analysis of product and process data.
• Complete test method validation and support regulatory and internal audits with validation expertise and documentation.
• Drive root cause investigations and corrective actions, mentor junior engineers, and improve validation standards and practices.

Requirements

• Bachelor’s degree at Level 8 or higher in engineering or science.
• 5–7 years of experience in quality engineering or medical devices, with significant validation experience.
• Expertise in IQ/OQ/PQ, risk management, and equipment and validation lifecycle management.
• Working knowledge of statistical data analysis, problem-solving, and quality improvement tools.
• Ability to multitask, take initiative, communicate effectively, and collaborate across functions.
• Experience working with ISO 13485, FDA QSR, EU MDR, and internal quality systems is required for the validation scope.

Culture & Benefits

• Full-time position supporting products that improve patient health and safety.
• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Cross-functional collaboration within a global healthcare technology organization.