Quality Lead

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

Quality Lead

Our client, a leading medical device manufacturer, is seeking a Validation Supervisor 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. You'll partner closely with Design Assurance, Engineering, Manufacturing, and Quality teams to ensure validation activities are executed in compliance with the Quality Management System and applicable regulatory requirements, playing a critical role in maintaining a compliant validated state.

Key Responsibilities

• 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.

Qualifications & Experience

• 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.
• Certified Quality Engineer (CQE) or equivalent professional certification is an advantage.