The Quality Assurance Specialist will be responsible for maintaining Quality Systems for NCR, CAPA, Complaint handling and Supplier Management following FDA and ISO 13485 regulatory requirements. The Specialist will monitor daily Manufacturing and QC activities to insure compliance with cGMP and the Premier Quality Management System. The Specialist reports to the Quality Manager.
• Maintenance of NCR system, including logging, tracking, implementation of Corrective Actions and effectiveness monitoring
• Conduct training associated with implementation of Corrective Actions
• Maintenance of CAPA system, including logging, tracking and effectiveness monitoring.
• Maintenance of Complaint handling system, including complaint logging and record creation.
• Conduct Internal and Supplier audits
• Prepare Supplier Agreements and maintain Supplier files as directed by Production Manager
• Maintenance of QC Inspection procedures and records.
• Creation and maintenance of Incoming Inspection documentation.
• Participate in product labeling activities including label preparation in compliance with UDI.
• Management of document control, including document revision and record maintenance
• Conduct cGMP and ISO13485 compliance training of Manufacturing and QC
• Manage and maintain Training Matrix and Records
• Additional responsibilities can be added as required.
Education & Experience
BS degree in a technical field or equivalent. 1-3 years work experience in medical manufacturing in a quality role is required. Strong working knowledge of cGMP/ ISO 13485 is required. Strong working knowledge of MS Excel and Word are essential. Knowledge of MS Access preferred. Auditing experience is preferred.