Supplier Quality Engineer II — Audit & CAPA Lead

Cook Polymer Technology in; Bloomington (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

Cook Polymer Technology in Bloomington, IN is seeking a Supplier Quality Engineer to qualify, approve, and monitor suppliers against ISO 13485 and FDA QSR. The role includes planning and conducting supplier audits, maintaining supplier quality agreements, and issuing SCARs.

You will lead supplier audits, manage corrective actions, monitor KPI trends, and drive continuous improvement across sourcing, quality, and regulatory activities.

Qualifications

• 4+ years of experience in medical device quality and supplier audits.
• Experience with ISO 13485, ISO 14971, and FDA QSR.
• Auditing lead auditor certification preferred.
• Proven process validation and CAPA experience.

Responsibilities

• Perform supplier quality audits and site visits.
• Manage supplier corrective action process and audit schedule.
• Monitor supplier non-conformance trends using risk-based methods.
• Track KPIs and participate in supplier performance reviews.
• Lead continuous improvement in supplier quality and process changes.
• Review supplier change notifications and raw material approvals.
• Coordinate with Quality Control on material issues.
• Support CAPA and non-conforming material processes.
• Assist internal and external audit programs.
• Risk assessment of suppliers and CAPAs.

Skills

Interpersonal skills

Statistics knowledge

Quality systems knowledge

Regulatory compliance familiarity

Education

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

Qualified Lead Auditor in ISO 13485 and/or ISO 9001

Job description

Cook Polymer Technology in Bloomington, IN is seeking a Supplier Quality Engineer to qualify, approve, and monitor suppliers against ISO 13485 and FDA QSR. The role includes planning and conducting supplier audits, maintaining supplier quality agreements, and issuing SCARs.

You will lead supplier audits, manage corrective actions, monitor KPI trends, and drive continuous improvement across sourcing, quality, and regulatory activities.