Teams at C&A Tool Engineering, Inc.

Conduct internal audits of manufacturing processes and quality systems against ISO 9001 requirements. Document audit findings, write reports, follow up on corrective action plans, and verify their effectiveness. The role requires collaboration with quality and manufacturing teams, attention to detail, strong communication, and travel among three facilities. First-shift scheduling requires flexibility.

Leads and executes equipment, process, and product validations; develops validation plans, protocols, and reports; supports product transfers and new product introductions; maintains medical device quality and regulatory compliance; drives CAPA and root-cause investigations; performs risk management, audits, quality trend analysis, and documentation control.

Maintains quality-related records and databases, transcribes and verifies information, organizes and scans customer-required documents, updates and distributes laboratory hot lists, imports and exports data using Excel, and prepares Certificates of Conformance for shipped products. The role requires Microsoft Office proficiency and physical ability to perform standing, bending, lifting, and other movement throughout an eight-hour shift.