Supplier Quality Engineer II: Audits, CAPA & Improvement

Cook Group; Bloomington (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Cook Polymer Technology in Bloomington, IN seeks a Supplier Quality Engineer to lead supplier qualification, audits, and ongoing monitoring ensuring compliance with quality standards and regulatory requirements. The role includes managing SCARs, supplier agreements, CAPA, and risk assessments while supporting QA, operations, and engineering.

Ideal candidates hold a BS in Engineering or related field with 4+ years in medical device quality, strong ISO 13485/14971 knowledge, and FDA QSR

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 ISO 13485, ISO 14971, Medical Device Directive, EU MDR 2017/745 and FDA QSR including 21 CFR Part 820 and Part 11, preferably in the medical device industry.
• Qualified Lead Auditor in ISO 13485 and/or ISO 9001 is preferred and will be required.
• 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.
• Candidates must be legally authorized to work in the United States; sponsorship not provided.

Responsibilities

• Perform supplier quality audits and supplier site visits; manage the supplier corrective action process and maintain the supplier audit schedule.
• Implement and develop mechanisms to monitor and identify supplier non-conformance trends based on risk.
• Track supplier quality performance measurements (KPIs) and participate in supplier performance reviews; approve supplier evaluations and monitoring as needed.
• Drive continuous improvement activities focusing on supplier quality and lead process improvements.
• Review and support Supplier Change Notifications; review and approve raw materials, first part approvals, and supplier process validations.
• Maintain supplier quality documentation with purchasing; liaise with QA to support incoming, in-process, and final QC for raw materials.
• Support CAPA, Non-Conforming Product Process and internal/audit programs; perform risk assessments of suppliers and materials.

Skills

Quality engineering

Auditing

Statistical analysis

Risk assessment

Process improvement

Communication

Education

B.S. in Engineering or related field

Job description

Cook Polymer Technology in Bloomington, IN seeks a Supplier Quality Engineer to lead supplier qualification, audits, and ongoing monitoring ensuring compliance with quality standards and regulatory requirements. The role includes managing SCARs, supplier agreements, CAPA, and risk assessments while supporting QA, operations, and engineering.

Ideal candidates hold a BS in Engineering or related field with 4+ years in medical device quality, strong ISO 13485/14971 knowledge, and FDA QSR