Experienced Quality Engineer required for a large Medical Device company based in Limerick. This is a full time position on a 7-12 month contract, offering an excellent salary and benefits.
The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams
Understand and review Validation documentation, Change Requests, Design and Process FMEA’s, Test Summaries, Software Validation, Microbiological assessments and Critical System Work Orders.
Provide Quality Engineering support to the Research and Development and Sustaining Engineering departments up to and including transfer to Production, understanding Design Assurance activities, reviewing associated documents including Design Verification/Design Validation, Design and Process FMEA, Process Validation and Test Summaries.
Support the Supplier Appraisal and Approval processes.
Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control.
Support of the Internal Audit, Supplier Audit and Regulatory Audit Programmes
Conducting, documenting and reviewing complaint investigations.
Risk assessment of customer complaints, Non-conformance and CAPA’s.
Initiate, manage and execute projects for continuous improvement within the department.
Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
Designee to the Senior Quality Engineer.
Third Level qualification in Science, Engineering or a relevant technical discipline.
Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
Proven knowledge and experience (ideally minimum 4 years) of working with ISO13485, ISO14971, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
Proven knowledge and experience of all aspects of Validation including Design, Process Validation and Software Validation.
Good working knowledge of statistics.
Experience in combination devices would be an advantage
For more information on this position please call Lee-Ann Enright on 061 336163 or alternatively apply online and a member of the Harmonics team will be in touch.