Quality & Validation Engineer Quality & Validation Engineer at Mergon Group in Castlepollard, Westmeath

Job description

• Job Description

Responsibilities

• 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.
• - 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
• - 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.

Requirements

• 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

Skills

Required

• Proficient computer skills

Benefits

• 26 days holidays
• Career Growth and Development Opportunities
• Company Gym
• Wellness Programme
• Employee Assistance Programme (EAP)