Supplier Quality Engineer 2

Regulatory Toolkit; Bloomington (IN); Sur place; USD 85 000 - 110 000; Plein temps

Résumé du poste

Regulatory Jobs in Bloomington, IN seeks a Supplier Quality Engineer to lead supplier qualification, audits, and CAPA activities to ensure compliance with ISO 13485, FDA QSR, and EU MDR requirements. You will monitor supplier performance, manage SCARs, and support quality documentation across purchasing, operations, and quality control.

The role emphasizes risk-based auditing, data-driven supplier improvements, and interaction with the broader Cook Medical Holdings quality program.

Qualifications

• B.S. in Engineering, Science, or a relevant technical discipline.
• Experience in Quality, Validation, or Statistics.
• Minimum 4 years experience with ISO 13485, ISO 14971, MEDICAL DEVICE DIRECTIVE/ MDR 2017/745 and FDA QSR (21 CFR Part 820/ Part 11).
• Lead Auditor in ISO 13485 and/or ISO 9001 preferred.
• Strong interpersonal and cross-functional collaboration skills.
• Authorized to work in the United States; Cook does not sponsor visas.

Responsabilités

• Perform supplier quality audits and site visits; manage SCARs.
• Monitor non-conformance trends based on risk.
• Track KPIs and participate in supplier performance reviews.
• Support CAPA program and quality system documentation.
• Coordinate with Quality Control and Purchasing on supplier issues.
• Support internal, vendor and regulatory audit programmes.
• Risk assessment of suppliers and materials.

Connaissances

Quality engineering

Auditing

Statistical methods

Risk assessment

Regulatory compliance

Formation

B.S. in Engineering or Science

Description du poste

Overview

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. Core responsibilities 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.

Responsibilities

• 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.

Qualifications

• 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.