Validation Lead

Hero Recruitment Group; Connacht; On-site; EUR 90,000 - 120,000; Full time

Job summary

Undisclosed Client in Ireland seeks a Quality Lead to spearhead a site-based team of Validation & Quality Engineers. You will plan and execute equipment and process validations for new product introductions, change controls, and strategic initiatives.

The role requires 8–12 years in validation/quality within regulated environments, strong ISO 13485 and FDA knowledge, and proven leadership. A proactive, data-driven problem-solver will thrive in this setting.

Qualifications

• Bachelor's degree in Engineering, Science, or related discipline (or equivalent).
• 8–12 years' experience in validation, quality engineering, or related roles in regulated industries.
• Experience in medical device, pharmaceutical, or similarly regulated manufacturing environments.
• Experience leading or supervising technical or quality teams.
• Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11.
• Experience with statistical analysis and validation tools.
• Experience supporting audits and regulatory inspections.

Responsibilities

• Lead and supervise a team of Validation & Quality Engineers with coaching and performance guidance.
• Plan and coordinate equipment, process, and test method validations for NPI, change control, and initiatives.
• Ensure validations comply with internal procedures and regulatory standards.
• Review and approve validation documentation including plans, risk assessments, protocols, and reports.
• Allocate resources and manage timelines to support project schedules.
• Act as site validation liaison with Design Assurance, R&D, Engineering, Manufacturing Ops, Supply Chain, and Quality.
• Support compliance activities including internal audits, inspections, and CAPA processes.
• Identify and drive continuous improvement in validation processes and standard work.
• Apply problem solving, risk-based decision making in a dynamic manufacturing environment.
• Communicate technical information to stakeholders including senior leadership.

Skills

Leadership

Validation

Quality engineering

Regulatory knowledge

ISO 13485

FDA 21 CFR 820/11

Problem solving

Education

Bachelor's in Engineering/Science

Job description

Our client, a leading medical device manufacturer, is looking for a Quality Lead to lead a site-based team of Validation & Quality Engineers.

This role is accountable for the effective planning, coordination, and execution of equipment and process validation activities supporting new product introductions, change control, and strategic initiatives.

In this role you will :

• Lead and supervise a team of Validation Quality Engineers, providing coaching, mentoring, and performance guidance.
• Plan and coordinate execution of equipment, process, and test method validations supporting new product development, change control, and strategic initiatives.
• Ensure validation activities are performed in accordance with internal procedures, regulatory requirements, and industry best practices.
• Review and approve validation documentation, including validation plans, risk assessments, protocols, reports, and deviation or exception documentation.
• Allocate resources and manage timelines to support project schedules and operational priorities.
• Act as site validation liaison with Design Assurance, R&D, Engineering, Manufacturing Operations, Supply Chain, and Quality functions.
• Support compliance activities including internal audits, inspections, and CAPA processes.
• Identify and drive continuous improvement opportunities related to validation processes, standard work, and compliance practices.
• Apply problem-solving, critical thinking, and risk-based decision-making in a dynamic manufacturing environment.
• Communicate complex technical information clearly to diverse stakeholders, including senior leadership

Ideally you will have:

• Bachelor's degree in Engineering, Science, or a related discipline, or equivalent experience.
• 8-12 years' experience in validation, quality engineering, or a related role within a regulated industry.
• Demonstrated experience working in medical device, pharmaceutical, or similarly regulated manufacturing environments.
• Prior experience leading or supervising technical or quality teams is required.
• Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11, and related regulatory standards.
• Experience with statistical analysis and validation tools.
• Demonstrated experience supporting audits and regulatory inspections.