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Abbott · 6 hours ago

Senior Manager Quality

Des Plaines, IL

Full-time

Onsite

Senior Level, Lead/Staff

$129K/yr - $259K/yr

9+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Manager Quality role provides leadership for the quality department, ensuring high quality levels on products while achieving efficiency and compliance with regulatory standards.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Oversee and execute the Nonconformance and CAPA subsystems, including Material Review Board (MRB) and CAPA Review Board activities, Material control processes, Investigations and root cause analysis, development and implementation of resolution plans and effectiveness checks to verify corrective actions

Apply Statistical Process Control (SPC) and process monitoring techniques to ensure product and process stability

Utilize statistical analysis to interpret data, identify trends, and drive continuous improvement initiatives

Implement and maintain risk management strategies to mitigate potential issues and ensure compliance with regulatory standards

Demonstrate strong critical thinking and problem-solving skills to support decision-making and process improvements

Interacts frequently with internal and external management and senior-level representatives concerning projects, operational decisions, scheduling requirements and or contractual clarifications

Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments

May supervise non-exempt employees

Keeps the organization's vision and values at the forefront of decision making and action

Demonstrates effective change leadership

Builds strategic partnerships to further departmental and organizational objectives

Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills

Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.)

Makes decisions regarding work processes or operational plans and schedules to achieve department objectives

Qualification

Nonconformance managementCAPA process managementStatistical Process ControlRisk managementProject managementLeadership skillsTeam collaborationCommunication skillsProblem-solving skills