Supplier Quality

• Manage the supplier quality program across OVIK Health locations, ensuring risk evaluations, audits, quality agreements, and annual performance reviews are completed
• Act as the primary Quality Point of Contact for critical suppliers
• Manage supplier deviations, approvals, and corrective action requests
• Manage and execute batch release activities for contract manufacturers
• Support the sterility program, including quarterly dose audits, annual review, and dose mapping
• Support the effectiveness of the division’s quality management system
• Participate in Management Review and conduct quality release testing as needed
• Assist with implementation and maintenance of a Quality System based on ISO 13485 and FDA Quality System Regulation
• Control quality-system documentation for Salisbury, Portsmouth, and division-wide documents
• Serve as subject matter expert for the Greenlight Guru electronic Quality Management System
• Monitor CAPAs, Customer Feedback, and Nonconformances
• Identify quality issues and communicate them to management
• Maintain quality-system procedures and controlled documents
• Assist in developing and maintaining quality-system training
• Assist in implementing inspection, measurement, and testing systems
• Track and report significant quality deviations
• Conduct Batch Record/Device History Record reviews, including sterile records
• Assist with quality inspection and product-release programs throughout production
• Participate in new product development to ensure quality assurance and control plans are ready before manufacturing
• Participate in internal, external, supplier, and FDA audits

Explore Supplier Quality – eQMS Specialist at Milliken & Company. Review requirements and application details.