Lead, Design Quality for Late-Stage NPI Devices

Regulatory Jobs; Chicago (IL); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in Chicago, IL is seeking an experienced Quality & Regulatory Lead for New Product Introduction (NPI) of combination products and medical devices. You will develop Regulatory, Quality and Product Development strategies in concert with cross-functional partners to ensure on-time delivery and full regulatory compliance.

Key responsibilities include leading design control activities, CAPA and risk management, ensuring proper interfaces to drug development, and guiding global product

Qualifications

• Bachelor's Degree in relevant Engineering, Life Science or equivalent required.
• 7+ years total experience; 5+ in Operations Quality Assurance.
• Knowledge of combination products, medical devices, and manufacturing processes.
• Experience with root cause investigations, CAPA, statistics and data analytics is a plus.
• Understanding of regulations affecting combination products and medical devices.
• Strong leadership, able to justify positions on quality issues.
• Ability to work independently and in global teams.

Responsibilities

• Serve as the primary quality lead for project activities to achieve on-time quality deliverables.
• Assure proper integration and support of device regulations and drug regulations.
• Perform design control activities and mentor product team members through the design process.
• Ensure design control documentation and assess impact of changes.
• Identify gaps in processes and lead cross-functional improvement initiatives.
• Support regulatory inspections and audits as SME.

Skills

Quality Assurance

Regulatory compliance

Design control

CAPA

Cross-functional collaboration

Leadership

Education

Bachelor's Degree in Engineering, Life Science or related field

Job description

AbbVie in Chicago, IL is seeking an experienced Quality & Regulatory Lead for New Product Introduction (NPI) of combination products and medical devices. You will develop Regulatory, Quality and Product Development strategies in concert with cross-functional partners to ensure on-time delivery and full regulatory compliance.

Key responsibilities include leading design control activities, CAPA and risk management, ensuring proper interfaces to drug development, and guiding global product