Quality Engineer II - Process Validation (Medical Devices)

Location: Athlone, County Westmeath, Ireland

Salary: EUR 49,920–74,880 per year, plus eligibility for the hirify.global Incentive Plan.

Company

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

What you will do

• Provide quality and process validation engineering support for new product introductions.
• Oversee end-to-end validation of processes, equipment, inspections, and products throughout the product lifecycle.
• Author, review, approve, and execute qualification and validation documentation.
• Perform statistical analysis and test method validation for inspection, testing, and production equipment.
• Support design and validation builds, production control, product evaluation, reliability, and research and development activities.
• Support audits, root-cause investigations, corrective actions, and quality problem-solving efforts.

Requirements

• Minimum Level 8 bachelor's degree in Quality, Engineering, Science, or a related discipline.
• At least 3 years of relevant experience in medical devices or a similar regulated environment.
• Knowledge of quality systems, validation standards, policies, procedures, and methodologies.
• Experience working effectively in cross-functional teams with strong organizational and time-management skills.
• Ability to prioritize, multitask, take initiative, and contribute to quality decisions.
• Validation activities must align with ISO 13485, FDA QSR, EU MDR, and internal quality system requirements.

Nice to have

• Working knowledge of plastic processing techniques, including extrusion, injection moulding, blow moulding, and assembly.
• Practical knowledge of statistical data analysis and quality improvement tools and techniques.

Culture & Benefits

• Full-time employment with a competitive salary.
• Flexible benefits package with resources intended to support employees across career and life stages.
• Short-term incentive eligibility through the hirify.global Incentive Plan.
• Cross-functional collaboration within a global healthcare technology organization.