Mergon
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Quality & Validation Engineer Quality & Validation Engineer
On-site · IrelandFull-timePosted 6 weeks ago
Mergon
ApplyMergon
Hiring now
On-site · IrelandFull-timePosted 6 weeks ago
Mergon
ApplyJob 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:
Mergon is an Equal Opportunity Employer that offers flexible working arrangements and values a diverse and inclusive workplace.