Quality Lead

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

Job summary

Hero Recruitment Group is assisting a leading medical device manufacturer in hiring a Quality Lead to head a site-based team of Validation & Quality Engineers. The role focuses on planning, coordinating, and executing equipment, process, and test method validations to support new product introductions, change control, and strategic initiatives.

The ideal candidate will have a Bachelor's degree in engineering or science, 8–12 years in validation or quality within regulated industries, and proven

Qualifications

• Bachelor's degree in Engineering, Science, or 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.

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

Skills

Team leadership

Quality engineering

Validation expertise

Regulatory knowledge

Education

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

Job description

Quality Lead

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.