Senior Medical Device Quality & Compliance Leader

SmartRecruiters, Inc.; Waco (TX); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie is seeking a senior QA Operations leader to oversee quality for devices and combination products, ensuring on‑time delivery and compliance with global regulations. You will guide cross‑functional teams, manage audits, and drive improvement with external manufacturers.

The role requires a strong regulatory background and 7+ years in QA/operations, with experience in validation, manufacturing, and CAPA. Location is in the US with on‑site work.

Qualifications

• Bachelor’s Degree in relevant Life Science or other technical field.
• Total combined years of experience: 7+ in QA operations, regulatory, or technical support.
• Strong analytical, problem‑solving and leadership abilities.
• Exposure to quality assurance/control, manufacturing, regulatory, or validation.

Responsibilities

• Ensure delivery of quality elements for on‑market support of devices and combo products.
• Lead global quality assurance strategy and provide oversight for product transfers and investigations.
• Coordinate audits, due diligence, and inspection readiness with internal and external partners.
• Drive CAPA, root-cause analysis, and corrective actions for non‑conformities.
• Interface with contract manufacturers to maintain quality and regulatory compliance.

Skills

Quality leadership

Regulatory knowledge

Analytical thinking

Problem solving

Stakeholder management

Education

Bachelor’s Degree in Life Science or technical field

Job description

AbbVie is seeking a senior QA Operations leader to oversee quality for devices and combination products, ensuring on‑time delivery and compliance with global regulations. You will guide cross‑functional teams, manage audits, and drive improvement with external manufacturers.

The role requires a strong regulatory background and 7+ years in QA/operations, with experience in validation, manufacturing, and CAPA. Location is in the US with on‑site work.