Mergon Group

Quality & Validation Engineer Quality & Validation Engineer

Mergon Group  •  Ireland (Onsite)  •  16 hours ago
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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 every day.

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 is Friday, 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.

Mergon Group

About Mergon Group

We design, develop and manufacture assemblies and components that are the essential ingredients in some of the world’s most famous, popular and innovative products. From automotive components to medical devices to industrial products, you’ll find Mergon-made components are part of the solution that brings ideas that matter to life.

For over 40 years, our experience and expertise has been trusted by many of the world’s most successful brands to help them adapt and reinvent. With operations in five countries , we have the capacity to meet today’s most challenging production requirements. And our culture of innovation supported with state-of-the-art technology ensures we’re ready for the challenges of the future.

Because at Mergon, we’re doing more than just making plastic parts; we’re moulding ideas for a sustainable future.

From manufacturing facilities in Ireland, the USA, Czech Republic, UK and Mexico, Mergon supplies high quality molded plastic products to international markets. Some of the world’s best-known brands and OEMs throughout Europe, North America and the Far East are among its customer base.

Established in 1981, the Group has enjoyed considerable growth and expansion. Its success is attributed to on-going investment in molding technology and an innovative approach to product design and development. Its extensive technical expertise covers all aspects of plastic molding, from initial concepts and design to prototyping and volume production.

As a market-leading plastic molding specialist, Mergon works closely with customers in creating innovative, quality products for diverse applications.

Industry
Chemicals & Materials
Company Size
501-1,000 employees
Headquarters
Castlepollard, IE
Year Founded
1981
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