Manager, Quality Assurance

Responsibilities

• Provide leadership to maintain Quality Management System compliance for Abbott Heart Failure in Atlanta
• Oversee the site’s compliance lifecycle, CAPA system, and External Requirements Management System
• Lead the CAPA program by providing strategic direction for robust investigations and global resolutions
• Serve as the primary interface with external regulatory bodies and manage internal and external inspections
• Drive audit readiness initiatives using risk-based prioritization to ensure the site is always compliant
• Evaluate and monitor results from external and internal audits and report findings to management
• Analyze trends to proactively address regulatory, compliance, and quality issues
• Lead, guide, and mentor a diverse, highly qualified staff to achieve business goals

Requirements

• Bachelor’s degree in a related field
• 8 years of Quality Systems, Quality Assurance, or Regulatory Compliance experience in medical device manufacturing
• 5 years of experience in a management capacity
• Knowledge of MDD, MDSAP, MDR, and NMPA regulations
• Knowledge of US CFR 803, 806, and 820
• Knowledge of ISO 13485 and 14971 standards

Preferred Qualifications

• Prior experience interfacing with Regulatory and Notified Bodies
• Hands-on experience managing CAPAs
• Experience with Supplier Quality
• Strong analytical, leadership, and communication skills
• Ability to manage multiple projects simultaneously in a detail-oriented environment

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.