Quality Manager

Quality Management Role

Quality Management contributes to Cardinal Health by developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. The role provides strategic oversight, leadership, and direction within the Quality function.

Responsibilities :

• Develop and implement quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
• Provide strategic oversight, leadership, and direction to direct reports within the Quality function.
• Manage, develop, train, and guide direct reports, quality staff, and site personnel to achieve site quality goals and maintain regulatory compliance.
• Lead audit readiness efforts and facilitate regulatory, customer, and corporate audits and provide responses to findings in a timely manner.
• Conducting Site Quality Management Reviews and report KPI metrics to corporate.
• Responsible for identifying trends and making decisions that affect product release to ensure patient safety.
• Responsible for understanding ISO 13485, FDA QSR, and other relevant standards and to apply them to continuous improvement of the Quality Management System.
• Manage internal audits, external audits, and regulatory inspections.
• Oversee document control, CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and complaint handling in a manufacturing environment.
• Support risk management activities, including hazard analysis and FMEA.
• Ensure quality oversight throughout product lifecycle from design control and supplier qualification to manufacturing and post-market surveillance.
• Collaborate with engineering, production, and supply chain teams to ensure product quality and process compliance.
• Train and mentor staff on quality procedures and regulatory requirements.
• Lead root cause analysis and problem-solving initiatives for quality issues.
• Analyze quality metrics and identify trends for escalation to senior management as required.

Qualifications :

What is expected of you and others at this level :

Anticipated salary range : $91,400 - $130,600 USD

Bonus eligible : Yes

Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

Application window anticipated to close : 12 / 12 / 2025

If interested in the opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidates geographical location, relevant education, experience, and skills and an evaluation of internal pay equity.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience, and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity / expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status, or any other status protected by federal, state, or local law.