NPI Design Quality Manager: Medical Devices & Combos

AbbVie; United States; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie seeks a Quality Assurance leader for New Product Introduction (NPI) of combination products and medical devices. You will act as the primary QA lead across project teams, drive design controls, and ensure compliance with global regulatory standards.

Collaboration with Regulatory Affairs, Marketing, and Product Development is essential to deliver on-time launches. The role requires a Bachelor's in Engineering or Life Sciences, 7+ years of experience (5+ in QA operations), and strong risk

Qualifications

• Bachelor's Degree in engineering or life sciences.
• 7+ years of total experience; at least 5 years in Operations QA.
• Knowledge of combination products, medical devices, and manufacturing processes.
• Understanding of regulations and standards affecting combination products and medical devices.
• Strong leadership, initiative, and ability to justify positions on quality issues.
• Experience with risk management methodologies and data analytics.

Responsibilities

• Serve as the quality lead for NPI projects to ensure on-time, compliant delivery.
• Ensure compliance with device, drug, and biologics regulations across teams.
• Lead design control activities and participate in design reviews with cross-functional partners.
• Manage design changes, traceability, and assess impact on safety and efficacy.
• Identify gaps in processes and lead cross-functional solutions.
• Support regulatory inspections and internal audits as QA SME.

Skills

Leadership

Regulatory knowledge

Risk management

Design control

Analytical problem solving

Cross-functional collaboration

Independent work

Communication

Education

Bachelor's Degree in Engineering or Life Sciences

Job description

AbbVie seeks a Quality Assurance leader for New Product Introduction (NPI) of combination products and medical devices. You will act as the primary QA lead across project teams, drive design controls, and ensure compliance with global regulatory standards.

Collaboration with Regulatory Affairs, Marketing, and Product Development is essential to deliver on-time launches. The role requires a Bachelor's in Engineering or Life Sciences, 7+ years of experience (5+ in QA operations), and strong risk