We are working on an exciting Quality Engineer role for a large medical device client in Clonmel.
Develop an in-depth knowledge of the manufacturing engineering process for the scope's products including all aspects of engineering production and process controls in place on these manufacturing lines.
Develop and/or review Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies, Design of Experiment (DOE), and production control plans in support of product transfer to ensure meets Quality engineering standards
Pro-actively implements Quality standards and procedures in the operational processes, to ensure that processes are executed per Corporate and Regulatory requirements.
Lead the translation and establishment of all Process Monitoring and activities, Acceptance Activities and inspections, and non-conforming material and product controls for the Scopes assembly lines in Clonmel.
Post-transfer identifies and controls Quality manufacturing engineer-related process defects (scrap, nonconforming material, customer complaints) by participating/leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
Leads Quality engineering process improvement efforts by identifying methods to capture Quality metric data and by performing appropriate Quality analysis methods to enhance sustaining product design and new product development.
Coordinates and conducts technical investigation and documentation of non-conforming events and trends and develop technical investigation plans using e CAPA and Engineering Essentials.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving Quality engineering issues.
Be part of a strong team culture around high expectations & high performance.
Provide clear communication to stakeholders at key technical updates.
Support and prepare for site level internal and external audits.
Support the transfer of the production lines
Required Qualifications:
2-5 years' experience in Manufacturing or Quality with a honours degree qualification in Engineering or related technical/Quality discipline.
Excellent written and verbal communication skills
Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
Strong command of MS Office – Word, Excel, Power Point.
Ability to rapidly learn and use new applications
Preferred Qualifications:
Previous experience in a Quality, or Manufacturing background.
Experience in the medical device industry.
Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.
Experience in problem solving and process improvement methodologies.
Process Validation, Risk Management, CAPA experience.
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