Senior Supplier Quality Engineer — Audits & CAPA

Regulatory Toolkit; Bloomington (IN); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality engineering

Auditing

Statistical methods

Risk assessment

Regulatory compliance

Educación

B.S. in Engineering or Science

Descripción del empleo

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.