Manager, Design Quality Late-Stage Development
AbbVie · North Chicago, IL
QualityFull timeCompany career page
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Role summary
AbbVie seeks a Manager of Design Quality for late-stage development of combination products and medical devices. The role involves leading quality strategies, ensuring regulatory compliance, and managing cross-functional teams to deliver compliant products on schedule.
What they're looking for
- Bachelor's degree in engineering, life science, or equivalent technical discipline
- 7+ years combined experience; at least 5 years in operations quality assurance
- 3+ years in operations, research and development, or consulting
- Comprehensive knowledge of combination products, medical devices, and manufacturing
- Understanding of device and drug regulations and design control processes
- Leadership skills with demonstrated quality standards advocacy
- Risk management and design control experience preferred
What you'll be doing
- Serve as primary quality lead for new product introduction projects and cross-functional teams
- Lead design control activities including design reviews and requirement verification
- Manage design change control and assess impacts on product safety and efficacy
- Oversee supplier and contract manufacturer quality agreements and compliance
- Support regulatory inspections, audits, and pre-approval inspection readiness
Privacy & handoff
This role links to AbbVie's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.