Supplier Quality Engineer 2

include the planning and execution of routine and for-cause supplier audits, maintenance of supplier quality agreements, MPIAs, NDAs, and associated supplier documentation, as well as the issuance, review, and follow-up of Supplier Corrective Action Requests (SCARs). The SQE provides quality engineering guidance and support to internal departments — including Operations, Engineering, and Quality Control — on all matters relating to supplier interfaces. This encompasses, but is not limited to, process and supplier validation, supplier change requests, non-conforming product issues, risk assessment, the Cook Polymer Technology Corrective and Preventive Action (CAPA) program, and associated Quality System documentation.

• ◆Perform supplier quality audits and supplier site visits; these are a key expectation of the role. Manage the supplier corrective action process and maintain and update the 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 (KPIs) 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; a strong inclination and proactive approach to identifying and implementing process improvements is a key expectation of this role.
• ◆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 Polymer Technology 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 CAPAs.
• ◆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.
• ◆Interaction with Cook Medical Holdings (parent company) on quality-related matters as required.

• ✓B.S. in Engineering, Science, or a relevant technical discipline.
• ✓Experience in Quality, Validation, or Statistics would be a distinct advantage.
• ✓Proven knowledge and experience (ideally minimum 4 years) of 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 gained 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 of 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.
• ✓Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.