Quality Engineer – REF NCHL01


•             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.

•             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 CAPA

•             Initiate, manage and execute projects for continuous improvement within the department.


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.

•             Good working knowledge of statistics

•             Strong interpersonal skill with the ability to communicate effectively at all organisational levels.





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