This role supports quality activities across manufacturing processes and materials, helping to ensure compliance with regulatory standards and internal quality systems.
The position plays a key part in maintaining product quality, supporting audits, and driving continuous improvement initiatives.
Key Responsibilities (include but are not limited to): Conduct inspections and product release reviews Perform audits and review quality documentation Monitor environmental conditions and oversee sample collection Manage non-conformances and support issue resolution Assist with quality metrics, validations, and process improvements Support manufacturing compliance across production, packaging, and labeling Maintain accurate documentation and work instructions Ensure adherence to CGMP, EHS policies, and training requirements Contribute to ongoing quality and compliance initiatives Requirements: Qualification in Quality, Science, Engineering, or relevant industry experience Minimum of 3 years' experience in a regulated environment (medical device, FDA, or ISO 13485 preferred) Proficiency in MS Office (Excel, Word, PowerPoint, etc.)
Knowledge of quality and statistical tools (e.g., Pareto analysis, trend analysis) Familiarity with root cause analysis techniques Strong verbal and written communication skills for technical and non-technical audiences This is a fully on-site role based in Athlone.
Skills: Quality Technical Science