Quality Manager, Medical Devices & Combination Products

AbbVie Inc.; Waco (TX); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical/Dental/Vision Insurance

401(k) plan

Job summary

AbbVie Inc. is seeking a senior Quality Assurance Operations Manager in Texas to ensure quality and regulatory conformance for combination products and medical devices. You will lead cross‑functional teams, drive risk assessments, and coordinate with contract manufacturers to meet on‑time delivery goals.

The role emphasizes a strong quality culture, strategic QA planning, and collaboration with Regulatory Affairs to support global product strategies across sites.

Qualifications

• Bachelor’s Degree in Life Science or related field required; graduate degree preferred.
• Minimum 7+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support.
• Strong analytical and problem‑solving skills with ability to lead and collaborate across teams.
• Experience with third-party external manufacturing and regulatory expectations.

Responsibilities

• Ensure delivery of quality elements for on‑market support of combination products and medical devices.
• Support Global Product Quality Assurance strategy and plant readiness.
• Make key decisions on quality, compliance and regulatory conformance and elevate risks to leadership.
• Lead SMEs and oversee project activities to achieve on‑time quality deliverables and cost efficiency.

Skills

Quality Assurance

Regulatory Compliance

Problem Solving

Leadership

Cross-functional Collaboration

Education

Bachelor's Degree in Life Science/Technical

Graduate Degree preferred

Job description

AbbVie Inc. is seeking a senior Quality Assurance Operations Manager in Texas to ensure quality and regulatory conformance for combination products and medical devices. You will lead cross‑functional teams, drive risk assessments, and coordinate with contract manufacturers to meet on‑time delivery goals.

The role emphasizes a strong quality culture, strategic QA planning, and collaboration with Regulatory Affairs to support global product strategies across sites.