Senior Validation Lead – Medical Devices

Hero Recruitment Group; Connacht; Vor Ort; EUR 85.000 - 115.000; Vollzeit

Zusammenfassung

Hero Recruitment Group is partnering with a leading medical device manufacturer to appoint a Validation Lead on site. You will lead a team of Validation Quality Engineers, oversee planning, execution, and documentation of validation activities supporting new product introductions and change control.

The role requires 8–12 years of experience in regulated environments, strong ISO 13485 and FDA knowledge, and proven leadership.

Qualifikationen

• 8–12 years' experience in validation, quality engineering, or a related role within a regulated industry.
• Experience in medical device, pharmaceutical, or similarly regulated manufacturing environments.
• Prior experience leading or supervising technical or quality teams.
• Strong working knowledge of ISO 13485 and FDA 21 CFR Parts 820/11.
• Experience with audits and regulatory inspections.

Aufgaben

• Lead and supervise a team of Validation Quality Engineers.
• Plan and coordinate validation of equipment, processes, and tests.
• Ensure activities comply with internal procedures and regulatory standards.
• Review and approve validation documentation (plans, protocols, reports, deviations).
• Allocate resources and manage timelines to meet project schedules.
• Liaise with Design Assurance, R&D, Engineering, Manufacturing, Supply Chain, and Quality.
• Support compliance activities including internal audits and CAPA.
• Identify and drive continuous improvement in validation processes.
• Apply problem-solving and risk-based decision making in manufacturing.
• Communicate complex technical information to diverse stakeholders, including senior leadership.

Kenntnisse

Team leadership

Regulatory knowledge

Problem solving

Communication

Risk-based decision making

Ausbildung

Bachelor's degree in Engineering, Science, or related

Tools

Statistical analysis tools

Jobbeschreibung

Hero Recruitment Group is partnering with a leading medical device manufacturer to appoint a Validation Lead on site. You will lead a team of Validation Quality Engineers, oversee planning, execution, and documentation of validation activities supporting new product introductions and change control.

The role requires 8–12 years of experience in regulated environments, strong ISO 13485 and FDA knowledge, and proven leadership.