Quality Validation Lead - Medical Devices

HERO Recruitment Ltd.; Ballina; On-site; EUR 85,000 - 110,000; Full time

Job summary

HERO Recruitment Ltd. on behalf of our client, a leading medical device manufacturer, is seeking a Quality Lead / Validation Supervisor to head a site-based team of Validation Quality Engineers.

You will plan, coordinate, and execute validation activities for equipment, processes, and test methods to support new product introductions and change control. You will partner with Design Assurance, Engineering, Manufacturing, and Quality to ensure activities comply with ISO 13485 and FDA regulations.

Qualifications

• 8–12 years of validation/quality engineering experience in regulated industries.
• Experience in medical device or pharmaceutical manufacturing environments.
• Proven experience leading or supervising technical or quality teams.
• Strong knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11.
• Experience with statistical analysis and validation tools.
• Certified Quality Engineer (CQE) or equivalent is an advantage.

Responsibilities

• Lead and supervise a team of Validation Quality Engineers.
• Plan and coordinate validation activities for equipment, processes, and tests.
• Ensure compliance with internal procedures and regulatory requirements.
• Review validation plans, protocols, reports, and deviations.
• Allocate resources and manage timelines to support schedules.
• Act as site validation liaison across Design Assurance, Engineering, Manufacturing, and QA.
• Support audits, inspections, and CAPA processes.
• Identify continuous improvement opportunities in validation processes.
• Communicate complex technical information to senior leadership.

Skills

Team leadership

Regulatory compliance

Quality engineering

Validation planning

Education

Bachelor's degree in Engineering, Science, or related field

Tools

Statistical analysis tools

Job description

HERO Recruitment Ltd. on behalf of our client, a leading medical device manufacturer, is seeking a Quality Lead / Validation Supervisor to head a site-based team of Validation Quality Engineers.

You will plan, coordinate, and execute validation activities for equipment, processes, and test methods to support new product introductions and change control. You will partner with Design Assurance, Engineering, Manufacturing, and Quality to ensure activities comply with ISO 13485 and FDA regulations.