Supplier Quality Engineer 2

About the role

The Supplier Quality Engineer (SQE) is responsible for the qualification, approval, and ongoing monitoring of suppliers to ensure compliance with Cook Polymer Technology quality standards and regulatory requirements. This includes planning and executing routine and for-cause supplier audits, maintaining supplier quality agreements, MPIAs, NDAs, and associated documentation, as well as issuing, reviewing, and following up on Supplier Corrective Action Requests (SCARs).

The SQE provides quality engineering guidance and support to internal departments—including Operations, Engineering, and Quality Control—on supplier interfaces, process and supplier validation, supplier change requests, non-conforming product issues, risk assessment, the Corrective and Preventive Action (CAPA) program, and associated Quality System documentation.

Responsibilities

• Perform supplier quality audits and supplier site visits.
• Manage the supplier corrective action process and maintain and update the supplier audit schedule.
• Implement and develop mechanisms to monitor and identify supplier non-conformance trends based on risk.
• Track supplier quality performance measurements (KPIs) and participate in supplier performance reviews.
• Complete and approve supplier evaluations and monitoring as required.
• Drive continuous improvement activities focusing on supplier quality; proactively identify and implement process improvements.
• Review and support Supplier Change Notifications.
• Review and approve 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 for Incoming, In-Process, and Final Quality Control for raw material issues.
• Provide input and support to the Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
• Support Internal Audit, Vendor Audit, and Regulatory Audit Programmes.
• Complete risk assessments of suppliers, non-conforming materials, and CAPAs.
• Ensure meaningful Quality measurement while prioritizing and acting on in-house or external Quality issues in a timely manner.
• Serve as designee to the Senior Quality Engineer/Quality Engineering Team.
• Interact with Cook Medical Holdings (parent company) on quality-related matters as required.

Qualifications

• B.S. in Engineering, Science, or a relevant technical discipline.
• Experience in Quality, Validation, or Statistics is a distinct advantage.
• Minimum 4 years of proven knowledge and experience working with ISO 13485, ISO 14971, 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 in the medical device industry.
• Qualified Lead Auditor in ISO 13485 and/or ISO 9001 is preferred and will be required in this role.
• Proven knowledge and experience in all aspects of Validation, including Process Validation.
• Good working knowledge of statistics.
• Strong interpersonal skills with the ability to communicate effectively at all organizational levels.