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.
Senior Quality Systems Engineer
Solventum, Westmeath, LE
Solventum, Westmeath, LE