Senior Medical Device Quality Leader

AbbVie Inc.; Kansas City (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

AbbVie is seeking a quality assurance operations leader to drive on-market quality of combination products and medical devices. You will lead a team of SMEs, define regulatory strategies, and ensure timely delivery while maintaining compliance across AbbVie plants and contract manufacturers.

This role requires strong analytical skills, a track record in QA/regulatory environments, and the ability to manage multiple complex tasks and cross-functional collaboration with global teams.

Qualifications

• Bachelor’s Degree in Life Science or other technical field.
• Minimum of 7+ years in QA Operations, Regulatory, Operations or Technical Support.
• Strong QA/control, manufacturing, laboratory, regulatory or validation background required.
• Experience handling third party external manufacturing requirements.

Responsibilities

• Ensure delivery of quality elements to support on-market products.
• Support Global Product Quality Assurance strategy and implement at AbbVie plants.
• Make key decisions on quality, compliance and regulatory conformance for devices and combination products.
• Lead collection, verification and improvement of quality metrics for management reviews.
• Lead a team of SMEs and oversee project activities to achieve on-time quality deliverables.
• Participate in development of global Product Quality Assurance strategy for devices and contract manufacturers.
• Communicate and negotiate with external quality organizations to balance service and cost.
• Interface with audit team to develop audit plans and corrective action timetables.
• Participate and lead product quality investigations and follow-up on complaint trends.
• Collaborate with internal/external partners on product quality feedback for management reviews.

Skills

Quality Assurance

Regulatory

Leadership

Analytical

Problem solving

Education

Bachelor's Degree in Life Science or technical field

7+ years in QA Ops/Regulatory/Tech Support

Job description

AbbVie is seeking a quality assurance operations leader to drive on-market quality of combination products and medical devices. You will lead a team of SMEs, define regulatory strategies, and ensure timely delivery while maintaining compliance across AbbVie plants and contract manufacturers.

This role requires strong analytical skills, a track record in QA/regulatory environments, and the ability to manage multiple complex tasks and cross-functional collaboration with global teams.