Quality Engineer II
Want to work for a company that is paving the way for minimally invasive technologies that are designed to eliminate the need for open surgery for patients worldwide?
Our Limerick based Medical Device manufacturing Client are seeking a Quality Engineer to join their team on a permanent basis to support multiple departments within the company such as 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 FMEAs, 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.
- Provide input and support to the Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
- 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 CAPAs.
- Provide quality engineering support to the Europe quality system.
- 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.
- Delegate to the Senior Quality Engineer/ Quality Engineering Team Lead.
Qualifications / Requirements:
- 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, EU Medical Device Regulation 2017/745 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.
For further information on this role in please contact Nigel on 086 8168273 or email science@hero.
Check out all our open jobs on our HERO Recruitment website https://www.hero.ie/
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