This innovative medical devices organisation has been enhancing medical diagnosis for over 20 years, developing a broad spectrum of immunoassays, chemistry, haematology, molecular urinalysis and blood gas testing systems. A pioneer in its field, this business invests heavily in technology to enhance medical diagnosis.
An opportunity has recently become available for a strong QA professional to join a developed Quality team based at their state of the art manufacturing plant in Dublin, which is currently seeing and undergoing expansion as a result of a new product being introduced to the site.
Reporting directly to the Quality Assurance Manager, some main duties include;
- Driving process measurement initiatives, including scorecards and other metrics, which are used to drive process quality improvements.
- Direct inputs and in some areas leading Quality Management system activities in areas including Validations, Process Change, Risk Assessment, CAPA, Complaint Handling, Non-conformances.
- Focus on and be responsible for process improvements and updating quality system procedures in Quality Assurance areas to achieve both fully compliant and lean processes.
- Using lean tools, own and lead quality projects that deliver quality, process and cost improvements.
- Using statistical analysis to support technical report writing to meet technical and regulatory standards of excellence. Examples include Gauge R&R, Capability Analysis, Sample Size Justification to support design changes, verifications, validations and deviations.
- Minimum of a Bachelor's degree in a relevant technical discipline (ideally Science or Engineering).
- A minimum of 5+ years relevant experience in a Quality role in the medical devices industry.
- Direct working experience in Manufacturing quality assurance for production and process controls. Experience in Validations and Change management, in particular, would be an advantage.
- Experience assessing manufacturing's capability to meet quality requirements based on digital data analysis and internal audit. Ability to create concise reports that enable project teams to implement improvements and corrective actions.
- Experience with Design Transfer support through the review and approval of plans and reports ensuring they meet regulatory and technical standards. To ensure that new equipment and processes are fit for purpose and commissioned correctly.
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.