Overview
The primary function of this role is to provide Quality Engineering support to Production, Quality Control, Facilities, IT, Regulatory, Analytical Lab, Research and Development, New Product Introduction and Engineering Sustaining and Post Market teams. This includes, but is not limited to, providing support to design and process validation, change requests, nonconforming product issues, Corrective and Preventive Action program, risk management, trending analysis, audit support, microbiology and sterilisation review and associated Quality System Documentation.
Responsibilities
Understand and review Validation documentation, Change Requests, Design and Process FMEA's, Software Validation, Microbiological and Sterilisation assessments and Critical System Work Orders.
Provide Quality Engineering support to the Research and Development, New Product Introduction (NPI) and Sustaining Engineering departments up to and including transfer to Production, understanding Design Assurance activities, reviewing associated documents including Design Inputs, Design Verification/Design Validation, Design and Product transfer, Design and Process FMEA and Process Validation.
Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control.
Drive the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
Drive field action assessments and support field action.
Support of the Internal Audit and Regulatory Audit Programmes. Represent Quality Engineering in audits.
Analyse quality data to identify trends, highlight systemic risk, and drive improvement actions
Initiate, manage and execute projects for continuous improvement within the department.
Ensure that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
Provides informal mentoring and technical guidance to QE1s.
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.
Minimum of 3 years experience in a quality engineering role or related technical discipline.
Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
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.
The ability to make independent, risk based quality decisions within QMS and regulatory frameworks.
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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