Supplier Quality Engineer II — Audits & Continuous Improvement

Cook Medical Inc.; Bloomington (IN); In loco; USD 85.000 - 120.000; Tempo pieno

Descrizione del lavoro

Cook Polymer Technology is seeking a Supplier Quality Engineer 2 to lead supplier audits, monitor supplier performance, and drive CAPA and change notifications. You will collaborate with Operations, Engineering, and Quality Control to ensure medical-grade supplier compliance.

The role requires 4+ years in quality/validation, strong regulatory knowledge, and Lead Auditor credentials, with US work authorization. Bloomington, IN on-site position with 20-30% travel.

Competenze

• B.S. in Engineering, Science, or a relevant technical discipline.
• 4+ years of experience in quality, validation, or statistics.
• Knowledge of ISO 13485, ISO 14971, and FDA QSR (21 CFR Part 820/11) in medical devices.
• Lead Auditor certification preferred.
• Strong communication and cross-functional collaboration.
• Authorized to work in the United States; no visa sponsorship.

Mansioni

• Perform supplier quality audits and site visits.
• Manage supplier corrective action process and audit schedules.
• Monitor supplier performance metrics and conduct evaluations.
• Support CAPA, supplier change notifications, and validation activities.
• Collaborate with QA, Operations, and Engineering.

Conoscenze

Quality engineering

Validation

Statistics

Auditing

Regulatory knowledge ISO 13485

Process Validation

Formazione

B.S. in Engineering/Science or relevant technical discipline

Strumenti

ISO 13485

Lead Auditor

Process Validation

Descrizione del lavoro

Cook Polymer Technology is seeking a Supplier Quality Engineer 2 to lead supplier audits, monitor supplier performance, and drive CAPA and change notifications. You will collaborate with Operations, Engineering, and Quality Control to ensure medical-grade supplier compliance.

The role requires 4+ years in quality/validation, strong regulatory knowledge, and Lead Auditor credentials, with US work authorization. Bloomington, IN on-site position with 20-30% travel.