Global Quality Engineering Lead (Medical Devices)

K3 Innovations; United States; Hybrid; USD 120,000 - 190,000; Full time

Job summary

AbbVie seeks a Quality Engineering Project Manager to lead a team of quality engineers supporting manufacturing processes, validation, and qualification. You will ensure quality systems compliance and drive risk-based decisions across base business and expansion initiatives.

You will manage resources and budgets, collaborating with Manufacturing, Regulatory, and Development to enable compliant production improvements and technology transfers.

Qualifications

• Bachelor's degree in physical or life sciences, pharmacy or engineering.
• CQE certification or formal training in quality engineering or statistics preferred.
• 8+ years in Manufacturing, QA, QC, R&D in pharma, biologics, device or chemical industry.
• 4+ years of supervisory/technical leadership experience.
• Familiar with cGMP and regulatory requirements.
• Experience with statistical quality systems and EDMS/LIMS.

Responsibilities

• Leads and develops a team of quality engineers supporting manufacturing quality oversight, validation, qualification, and compliance activities.
• Provides functional leadership for quality engineering activities across manufacturing processes, equipment, utilities, facilities, and associated systems.
• Guides quality engineering matters related to base business operations, development, tech transfer, and market expansion projects.
• Ensures validation and qualification strategies and lifecycle activities comply with AbbVie Quality Systems and cGMP.
• Reviews quality and compliance gaps related to manufacturing processes and drives risk-based actions.
• Partners with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development to support compliant implementation of processes.
• Guides risk management activities including assessments and mitigation planning.

Skills

Global product transfers

Communication skills

Manufacturing line setup

Quality engineering leadership

Quality risk management

Education

Bachelor's degree in Physical or Life Sciences, Pharmacy, or Engineering

Certified Quality Engineer (CQE)

Tools

Statistical quality systems

Electronic document management (EDMS)

Laboratory information management (LIMS)

Job description

AbbVie seeks a Quality Engineering Project Manager to lead a team of quality engineers supporting manufacturing processes, validation, and qualification. You will ensure quality systems compliance and drive risk-based decisions across base business and expansion initiatives.

You will manage resources and budgets, collaborating with Manufacturing, Regulatory, and Development to enable compliant production improvements and technology transfers.