Our Client a well-established start-up based here in Galway are looking for a Quality Engineer.
As the quality engineer, you will provide quality support for daily operational activities with particular emphasis on Manufacturing Process Support, CAPA, Problem Solving, Lean Six Sigma activities, Rework activities, Risk Management, Supplier Management, Auditing, Non-conforming materials disposition, Calibration, Incoming Inspections, In-Process Inspections, and Process Validation.
Generation of Protocols, Reports, Work Instructions, Forms, and Procedures. You will also support process development, operational effectiveness, the product realization process, and the QMS.
Reporting to the Principal Quality Engineer or designee.
- Provide Quality support at daily production meetings and weekly Production Planning meetings.
- Perform regular audits including 5S on production processes.
- Raise and participate in corrective actions where a non-conformance has been identified.
- Lead and coordinate investigations on defective parts at incoming inspection, utilizing appropriate root cause analysis tools and techniques.
- Initiate / Approve Manufacturing Rework Instructions
- Participate / Lead Risk Analysis initiatives e.g. FMEA
- Support the creation of work instructions, visual standards, and test instructions relating to manufacturing.
- Initiate/review/approve Document Change Notifications (DCNs) associated with manufacturing.
- Provides Quality support for the transfer of new products into commercialization.
- Supports validation activities including MVPs, TMVs, OQ/PQ, PPQ, and revalidation assessments.
- Perform statistical analysis using Minitab.
- Develop and implement cost/value Improvement Projects, utilizing lean six sigma tools and techniques.
- Support activities associated with Sterilization.
- Support First Article Inspection (FAI) activities.
- Supports the vendor change notifications (VCNs) process.
- Provision of Operations metrics for Management Review.
- Represent Quality at both internal and external audits and lead preparation activities in advance of such audits.
- Support the development, writing, and compiling of the Design History Files, Technical Files,
- Design Dossiers; PMA and 510k submissions for Notified Bodies, FDA, and Competent Authorities where necessary.
- Degree qualified in related technical discipline or specific recognized qualifications in a quality-related discipline.
- Minimum 3 years experience in an operations role within the Medical Device or Pharmaceutical Industry.
- Experience and understanding of regulations related to medical devices e.g. ISO 13485,
- MDD, MDR, and applicable FDA Requirements.
- Experience in writing documentation in a regulated environment.
- Experience in conducting audits in a regulated environment.
- Effective information gathering.
- Ability to prioritize tasks.
- Excellent verbal and written communication skills.
- Excellent technical writing skills.
- Methodical approach to lead change and drive continuous improvement.
- Proficient in the use of desktop software e.g. excel, word.
- Desirable to have experience in using statistical software or utilizing statistical techniques.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717