Quality Engineer Job Summary
This role provides Quality Engineering support to Production, Quality Control, Purchasing, Facilities, IT, Regulatory, Analytical Lab, Research and Development and Engineering Sustaining teams. The primary function of this role is to provide Quality Engineering support in various areas including process validation, change requests, non-conforming product issues, Cook Medical Corrective and Preventive Action program, Design and Process FMEA, risk assessment and associated Quality System Documentation.
Responsibilities:
* 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 Cook Medical 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's.
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 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.
* Good working knowledge of statistics.
* Experience in combination devices would be an advantage.