Patient Safety Operational Specialist

Responsibilities

• Support Abb Vie’s global quality assurance function for medical devices and combination products to ensure products meet customer and regulatory requirements.
• Analyze and collect data for product or quality system issues to support continuous improvement.
• Support regulatory inspections for medical devices and combination products.
• Process and maintain SOPs for the business segment; compile quality data and trends for Quality Management and Product Reviews.
• Provide support and manage regulatory inspections and track inspectional responses; serve as training coordinator.
• Maintain knowledge of current and emerging GxP requirements and quality trends; support and execute changes to quality standards/policies to ensure conformance.
• Handle organization effectiveness tasks (memos/letters, correspondence, scheduling, filing systems, basic reports, statistics, database setup).
• Assist with special projects by collecting and collating documents and materials.
• Compile and generate reports, timelines, correspondence, and presentations.

• Bachelor’s degree required in a scientific discipline or equivalent experience.
• 5+ years of combined experience in Manufacturing, QA, and/or R&D in pharmaceutical, biologics, device, or chemical industry.
• Demonstrated knowledge of quality systems, CAPA, and tools for managing global quality performance in a regulated industry.
• Ability to work in a multinational, multicultural, highly matrixed environment.
• Strong oral and written communication skills.
• Proficient computer skills with hands‑on experience in database management, spreadsheets, project management, presentations, word processing, and/or flowcharting software.