The QA Validation Engineer is responsible for coordinating, implementing, and maintaining the site validation program to ensure compliance with external regulatory requirements and industry best practices. The role involves oversight of validation activities for equipment, utilities, processes, and software, as well as participation in broader Quality Assurance initiatives.

KEY RESPONSIBILITIES:

Validation & Quality Assurance

• Coordinate, direct, and actively participate in validation and QA activities for site equipment, utilities, processes, and software.
• Ensure compliance with FDA, European cGMP, and GAMP standards.
• Develop, maintain, and execute the Site Validation Master Plan and Project Validation Plans.
• Generate validation protocols, reports, and investigations to meet cGMP standards.
• Implement corrective actions as identified through validation investigations.

Documentation & Compliance

• Create, review, and approve quality documents and test data.
• Manage validation, exception events, and change control processes.
• Maintain validation equipment records and ensure accurate tracking.
• Document all activities per cGMP requirements and update procedures to reflect current best practices.

Training & Continuous Improvement

• Complete all required training before performing tasks.
• Cross-train within the team and support onboarding of new team members.
• Participate in continuous improvement initiatives across manufacturing, quality, safety, and training systems.

Communication & Team Collaboration

• Coordinate team activities for maximum efficiency.
• Maintain overall cGMP compliance in production areas.
• Communicate effectively with peers and management, escalating issues as needed.

REQUIREMENTS:

Essential Qualifications

• Qualification and/or degree in engineering or a scientific discipline.

Experience & Skills

• 3+ years of validation or quality experience in medical device plastics processing, moulding, or assembly operations.
• 3+ years of knowledge in cGMP and regulatory requirements for the medical device industry.
• Strong communication (written and oral), presentation, and troubleshooting skills.
• Effective interpersonal and organizational skills.
• Ability to work independently and collaboratively in a team environment.
• Strong prioritization and multitasking abilities.

Cognitive Skills

• Ability to identify systems and processes requiring validation or QA support, ensuring timely documentation and resolution.
• Strong communication and motivation skills.

Apply today!

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters
For further information on this role please contact Róisín Vaughan on 086 440 3742 / consult@hero.ie

Check out all our open jobs on our HERO Recruitment website - HERO Recruitment: Leading STEM Recruitment Agency 

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.