Global Medical Device Quality Lead

AbbVie; Waco (TX); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

AbbV ie seeks a senior professional to lead Quality Assurance Operations Management, overseeing regulatory conformance and product quality for devices and combination products. Responsibilities include strategic QA planning, cross-functional leadership, and driving corrective actions across manufacturing sites and contract manufacturers.

You will coordinate with regulatory teams, internal auditors and suppliers to ensure timely, compliant product transfers and on-market support.

Qualifications

• Bachelor's degree in life science or related field; graduate degree preferred.
• Minimum 7+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support.
• Ability to manage multiple complex tasks with urgency and strong problem solving.

Responsibilities

• Ensure delivery of quality elements to facilitate on-market support for products.
• Support Global Product Quality Assurance strategy at AbbVie plants.
• Make key decisions on product quality, compliance and regulatory conformance.
• Lead collection, verification and improvement of Quality metrics for management reviews.
• Lead a team of SMEs for on-time quality deliverables and product transfers.
• Participate in development of global PQAS strategy for device and combination products.
• Negotiate with external quality organizations to balance quality and cost.
• Interface with audit team to develop audit plans and inspection readiness.
• Lead product quality investigations and CAPA management.
• Collaborate with internal and external partners for feedback in management reviews.

Skills

Quality Assurance

Regulatory Affairs

Leadership

Analytical Skills

Problem Solving

Cross-functional

Education

Bachelor’s Degree in Life Science

Graduate degree preferred

Job description

AbbV ie seeks a senior professional to lead Quality Assurance Operations Management, overseeing regulatory conformance and product quality for devices and combination products. Responsibilities include strategic QA planning, cross-functional leadership, and driving corrective actions across manufacturing sites and contract manufacturers.

You will coordinate with regulatory teams, internal auditors and suppliers to ensure timely, compliant product transfers and on-market support.