Our client, a medical device manufacturing company, has an immediate opening for a Quality System Manager. This role is responsible for managing and maintaining the Quality System by coordinating document change activities and monitoring compliance to ISO13483 and cGMP 21CFR part 820 quality assurance requirements.

Responsibilities:

• Compile certification documents, perform final packaging/labeling audit, and release product for shipment
• Liaison with regulatory reporting agencies and environmental consultants
• Monitor applicable quality systems through trending analysis, compiling metrics, and developing reports on a regular basis
• Perform and document customer complaint investigations. Assist Quality Manager with findings to assure actions are effective
• Provide support to manufacturing, project, and product development activities
• Perform Vendor Onboarding and Periodic Assessment for Critical Materials
• Lead and drive Supplier corrective action (SCARs) on process and product-related quality issues. Follow-up on supplier corrective action, evaluate responses, and ensure objective evidence substantiates adequate closure
• Other responsibilities as required

Requirements:

• 10+ years of similar work experience
• Bachelor of Science degree preferred
• Ability to read and interpret engineering drawings
• Detailed understanding of regulatory and compliance protocols for ISO 13485 and cGMP 21 CFR part 820
• Must be capable of developing procedures, work instructions, flow charts, and forms in support of the quality system requirements
• Strong facilitation/communication/training skills are strongly recommended
• Experience with IQMS ERP is a plus