Senior Validation Lead - Quality & Compliance

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

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.