Lead Validation Engineer, Medical Devices

HERO Recruitment Ltd.; Ballina; On-site; EUR 70,000 - 110,000; Full time

Job summary

HERO Recruitment Ltd. is seeking a Validation Supervisor to lead a site-based team of Validation Quality Engineers in Ballina.

You will plan, coordinate, and execute equipment and process validations to support new product introductions, changes, and strategic initiatives, ensuring compliance with the Quality Management System. The role requires strong regulatory knowledge (ISO 13485, FDA 21 CFR Parts 820/11), problem-solving skills, and the ability to communicate complex technical information

Qualifications

• Bachelor's degree in Engineering, Science, or related discipline, or equivalent experience.
• 8–12 years' experience in validation or quality engineering within regulated industry.
• Experience in medical device/pharma manufacturing environments.
• Experience leading or supervising technical or quality teams.
• Strong knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11, and related standards.
• Experience with statistical analysis and validation methods.
• CQE or equivalent certification is a plus.

Responsibilities

• Lead and develop a site validation team of engineers.
• Plan and coordinate equipment, process, and test method validations.
• Ensure activities comply with internal procedures and regulatory standards.
• Review and approve validation docs (plans, protocols, reports, deviations).
• Allocate resources and manage timelines for projects.
• Collaborate with Design Assurance, R&D, Engineering, Manufacturing, QA.
• Support audits, inspections, CAPA, and continuous improvement initiatives.

Skills

Team leadership

Quality engineering

Validation expertise

Regulatory compliance

Risk assessment

Statistical analysis

Problem solving

Communication

Education

Bachelor's degree in Engineering/Science

CQE certification (advantage)

Job description

HERO Recruitment Ltd. is seeking a Validation Supervisor to lead a site-based team of Validation Quality Engineers in Ballina.

You will plan, coordinate, and execute equipment and process validations to support new product introductions, changes, and strategic initiatives, ensuring compliance with the Quality Management System. The role requires strong regulatory knowledge (ISO 13485, FDA 21 CFR Parts 820/11), problem-solving skills, and the ability to communicate complex technical information