As a Senior Quality Engineer, you will provide technical leadership and drive projects in a structured fashion. You will be responsible for managing project activities, ensuring timely completion of milestones, and representing the team at review meetings.
Key Responsibilities
* Drive all assigned quality engineering projects and ensure they are managed in compliance with relevant procedures.
* Manage and drive project activities to ensure timely completion of project milestones.
* Represent the team at key review meetings.
* Build effective relationships with other functions, particularly Operations, IT, Engineering, and Regulatory teams.
You will lead in the area of FDA, QSR, and ISO requirements, promoting awareness of best industry practice and making appropriate decisions on a daily basis.
Maintain a proactive approach to developing the quality system to meet the changing needs of the business.
Evaluate and implement opportunities for improvement and initiate corrective actions under your own initiative.
Perform supplier quality audits and manage the supplier corrective action process.
Implement and develop mechanisms to monitor and identify supplier non-conformance trends based on risk.
Track supplier quality performance measurements for suppliers (KPIs) and participate in supplier performance reviews.
Complete and approve 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.
Maintain 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, Supplier Audit, and Regulatory Audit Programmes.
Completion of risk assessment of suppliers, non-conforming materials, and CAPAs.
Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritized and acted upon in a timely manner.
Ensure that Code of Conduct is considered in all business matters carried out on behalf.