Quality & Validation Engineer Quality & Validation Engineer

Mergon Group; Castlepollard; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

26 days holidays

Career Growth and Development Opps

Company Gym

Wellness Programme

Employee Assistance Programme (EAP)

Job summary

Mergon Group is seeking a Quality & Validation Engineer in Ireland to support QA and validation activities, ensuring high-quality systems and regulatory compliance. The role includes executing validation protocols, data analysis, and driving investigations for deviations and CAPAs.

The candidate will contribute to ISO 13485 and ISO 9001 compliance, participate in internal audits, and support new product development and production trials with a focus on continuous improvement.

Qualifications

• Ordinary Degree in Science, Engineering or a related field.
• Minimum 2 years experience in quality within an ISO 13485 environment.
• Internal Auditor qualified to ISO 13485 is preferred.
• Strong interpersonal, problem solving and attention to detail skills.
• Experience with equipment validation and statistical analysis is desirable but not essential.
• Proficient computer skills.

Responsibilities

• Provide QA support to ensure the Quality System meets high standards focusing on validations and non-conformances.
• Write and execute validation protocols and reports for new products and revalidations (IQ, DOE, Stability, OQ, PQ).
• Carry out data analysis on validation data and prepare reports with recommendations.
• Ensure traceability and audit readiness for internal and regulatory audits/inspections.
• Support investigations and closure of Validation Deviations and CAPAs.
• Assist with maintaining the quality system to ISO 13485 and ISO 9001 standards, and support SOP creation and revisions.

Skills

Interpersonal skills

Problem solving

Attention to detail

Proficient computer skills

Statistical analysis

Education

Ordinary Degree in Science/Engineering

Job description

Job Description

Who we are?

At Mergon, we mould ideas for a sustainable future. We work with leading brands like Tesla, BMW, Xerox and Abbott to design, manufacture and deliver sustainable products for the vehicles and equipment of the future.

We care deeply about our colleagues, customers and our community and we have a curiosity that constantly pushes us to innovate and improve. We are competent, capable and we invest in our people and in our processes to ensure we continue to grow and do our best work everyday.

We currently have a vacancy for a Quality & Validation Engineer to join our team

What you will do:

Provide Quality Assurance support to ensure the Quality System is of the highest standard with particular focus on validations and non-conformances. This is a development opportunity, and the successful candidate will receive the relevant training and development plan to own the following processes/actions.

Validation:

• - Write and execute validation protocols and reports for new product introductions, and revalidations including IQ, DOE & Stability, OQ and PQ ensuring compliance with regulatory standards (ISO13485 etc.)


• - Complete data analysis on validation data for the generation of reports and propose informed decisions/recommendations based on this analysis.


• - Ensure traceability and audit readiness of all validation activities for internal and regulatory audits/inspections.


• - Manage investigation and closure of Validation Deviations

Quality:

• - Assist with maintaining the quality system to international standards ISO 13485, ISO 9001 and all applicable regulations under the Medical Device regulation, including creation of new SOP’s and revision of existing documentation within the quality management system for both medical and non-medical products and processes.


• - Carryout internal audits to the ISO 13485 standard.


• - Participate in and support new product development projects, production trials, sampling and production runs of new materials and finished products as needed.


• - Assist with driving continuous improvement processes within the organisation through change control activities.


• - Manage investigation and closure of non-conformances and CAPA’s, including support of the investigation processes when not the owner.

A desirable background for this role:

• Ordinary Degree in Science, Engineering or a related field


• Minimum 2years experience working in quality in an ISO 13485 regulated environment.


• Internal Auditor qualified to ISO 13485


• Strong interpersonal, problem solving and attention to detail skills.


• Experience with equipment validation and statistical analysis is desirable but not essential.


• Proficient computer skills

Closing date for receipt of applications isFriday, 25th September 2026

Benefits:

• 26 days holidays


• Career Growth and Development Opportunities


• Company Gym


• Wellness Programme


• Employee Assistance Programme (EAP)

Mergon is an Equal Opportunity Employer that offers flexible working arrangements and values a diverse and inclusive workplace.