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.
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.
