Quality Compliance Program Manager

Abbott

Abbott seeks a Quality Compliance Program Manager to lead compliance initiatives, audit readiness, and quality programs within its Electrophysiology division. The role partners across manufacturing, quality, regulatory, and commercial functions to strengthen quality culture and drive strategic compliance objectives.

Responsibilities

Develop and execute global quality and compliance strategies aligned with divisional priorities and business objectives
Lead external audit lifecycle including preparation, execution, response management, and follow-up activities
Drive inspection readiness across global sites for FDA, Notified Body, and other regulatory inspections
Own standards and regulation change management activities with impact assessments and implementation plans
Support field actions, Health Hazard Evaluations, and critical quality events coordination

Requirements

Bachelor's degree in Engineering, Life Sciences, Industrial Technology, or related field
10+ years experience in Quality, Compliance, Manufacturing Operations, Regulatory Affairs, or related functions
Demonstrated experience leading large cross-functional programs in regulated industries
Strong knowledge of Quality Management Systems and compliance processes
Ability to influence stakeholders and drive results in matrixed global organizations
Excellent communication, presentation, and executive-facing leadership skills
Preferred: Medical device or pharmaceutical industry experience

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Vacancy posted 3 days ago

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