Overview 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. This includes, but is not limited to, providing support to 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.
Reporting to: Team Lead, Quality Engineering
Department: Quality Engineering
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. Provide quality engineering support to the Cook Medical 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. Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Qualifications 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. Experience in combination devices would be an advantage. Strong interpersonal skill with the ability to communicate effectively at all organisational levels. The ability to challenge thinking/opinion/actions in light of ensuring Cook Medical Quality Systems and Processes are adhered to. High attention to detail in all aspects of the role. Excellent organisational skills. Proven problem-solving skills. High self motivation. Good working knowledge of Microsoft Office. Willingness and availability to travel on company business.
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