Senior Quality Engineer

What Quality Engineering contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Responsibilities:

• Ensure compliance with site and corporate Quality Management Systems (QMS), support the overall QA system, and conduct relevant quality system training.

• Lead and support internal audit programs, including conducting audits and developing corrective/preventive actions, while also participating in external regulatory, supplier, and customer audits.

• Drive comprehensive CAPA, SCAR, and nonconformance programs, focusing on root cause analysis, corrective/preventive actions, and tracking their effective closure.

• Monitor and manage supplier performance, initiate and track Supplier Corrective Action Requests (SCARs), and conduct supplier audits to ensure quality standards.

• Collect, analyze, and report key quality metrics and trends, weekly and quarterly for management review, utilizing statistical tools for data-driven insights and decision-making.

• Develop and present Quality Alerts, lead cross-functional quality improvement projects, and drive continuous improvement initiatives on the production floor.

• Develop specifications and test methods, perform process risk assessments (PFMEA), review new/modified designs and Document Change Requests (DCRs) for compliance, and maintain control plans, sampling, and environmental/sterilization controls.

• Provide dedicated quality engineering support for new product development and process transfer projects, representing the Quality function on project teams.

• Conduct thorough customer complaint investigations, determine root causes, and facilitate Material Review Board (MRB) for the disposition of nonconforming products.

• Performs other job duties as assigned.

Qualifications:

• Bachelor’s degree in related field, or equivalent work experience, preferred

• 2+ years’ experience in related field, preferred

• Understanding of FDA regulations surrounding the manufacturing of medical devices, GMPs and process validations, preferred

• Able to apply working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks

• Experience working on projects of moderate scope and complexity

• Ability to identify possible solutions to a variety of technical problems and take actions to resolve

• Able to exercise sound judgment within defined parameters

• Strong PC skills and knowledge of MS Office preferred

What is expected of you and others at this level:

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks

• Works on projects of moderate scope and complexity

• Identifies possible solutions to a variety of technical problems and takes action to resolve

• Applies judgment within defined parameters

• Receives general guidance and may receive more detailed instruction on new projects

• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $68,500 - $97,800

Bonus eligible: No

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

• Medical, dental and vision coverage

• Paid time off plan

• Health savings account (HSA)

• 401k savings plan

• Access to wages before pay day with myFlexPay

• Flexible spending accounts (FSAs)

• Short- and long-term disability coverage

• Work-Life resources

• Paid parental leave

• Healthy lifestyle programs

Application window anticipated to close: 11/21/2025 *if interested in 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 candidate’s geographical loca