Design Quality Lead – NPI Medical Devices & Combos

AbbVie Inc.; North Chicago (IL); Presencial; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid time off

Medical/dental/vision insurance

401(k)

Descripción de la vacante

AbbVie Inc. seeks a seasoned Quality lead for New Product Introduction (NPI) combination products and medical devices. You will shape regulatory, quality, and product development strategies with cross-functional partners to ensure on-time launches.

Lead design control activities, assess changes for safety and efficacy, and drive CAPA and risk management across AbbVie plants and contract manufacturers. Strong collaboration across global teams is essential.

Formación

• Bachelor’s degree in engineering, life sciences, or related field.
• 7+ years total experience; 5+ in Operations QA; 3 in Operations, R&D or Consulting.
• Knowledge of combination products, medical devices and manufacturing processes.
• Understanding of regulations and standards; capable of defending positions on quality issues.
• Experience with product development and design control approaches.
• Proficiency in risk management methodologies and data analysis.

Responsabilidades

• Serve as the primary quality lead for project activities and teams to achieve on-time quality deliverables.
• Ensure compliance with device, drug, and biologics regulations; support inspections and audits as SME.
• Perform design control activities; guide the product team through the design process and reviews.
• Identify gaps in processes and lead cross-functional teams for solution development and implementation.
• Coordinate with global and contract manufacturers to address quality concerns and readiness for inspections.
• Maintain relationships with suppliers and internal groups to manage quality requirements.

Conocimientos

Quality Assurance

Regulatory Knowledge

Leadership

Design Control

Risk Management

Cross-functional Collaboration

Analytical Thinking

Educación

Bachelor's Degree in Engineering or Life Science

Descripción del empleo

AbbVie Inc. seeks a seasoned Quality lead for New Product Introduction (NPI) combination products and medical devices. You will shape regulatory, quality, and product development strategies with cross-functional partners to ensure on-time launches.

Lead design control activities, assess changes for safety and efficacy, and drive CAPA and risk management across AbbVie plants and contract manufacturers. Strong collaboration across global teams is essential.