Quality Engineer 2, Supplier

Overview

The primary function of this role is to provide Quality Engineering support to the monitoring, approval and appraisal of suppliers from a quality perspective. Provide support and guidance to departments liaising with suppliers from an operations, engineering and quality control perspective. This includes, but is not limited to, providing support to process/ supplier validation, change requests, non-conforming product issues, Cook Medical Corrective and Preventive Action program, risk assessment and associated Quality System Documentation.

 

Reporting to: Team Lead, Quality Engineering  

 

 

 

Department:   Supplier Quality Engineering

 

Find out more about Cook Medical here

Responsibilities

• Department:   Supplier Quality Engineering
• Perform supplier quality audits and management of the supplier corrective action process. Maintain and update supplier audit schedule when required.
• Implement and develop mechanisms to monitor and identify supplier non-conformance trends based on risk.
• Track supplier quality performance measurements for suppliers (KPI’s) and participate in supplier performance reviews. Completion and approval of supplier evaluations and monitoring when required.
• Manage and drive continuous improvement activities focusing on supplier quality.
• Review and support Supplier Change Notifications.
• Review and approval of raw materials, first part approval and supplier process validations.
• Maintaining supplier quality documentation in conjunction with purchasing.
• Liaise with Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control for raw material issues.
• 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, Vendor Audit and Regulatory Audit Programmes.
• Completion of risk assessment of suppliers, non-conforming materials and CAPA’s.
• Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
• Designee 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.
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Qualifications

• Department:   Supplier Quality Engineering
• Third Level qualification in Science, Engineering or a relevant technical discipline.
• Qualification in Quality/Validation/Statistics would be a distinct advantage.
• Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
• Qualified Lead Auditor, preferably within the Medical Device Industry desirable.
• Proven knowledge and experience of all aspects of Validation including Process Validation and design validation.
• Good working knowledge of statistics.
• 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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