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Cardinal Health seeks a Quality Engineer to develop and implement quality policies, procedures, and processes ensuring compliance with ISO 13485 and FDA standards. You will oversee quality planning, evaluation, and control, working cross-functionally to drive prevention-based methodologies in design, manufacturing, testing, and correction of products and services.
Responsibilities include managing audits, coordinating with Operations and Engineering for compliance, and leading CAPA processes.
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 Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.
Responsibilities Responsible to develop and implement quality policies, procedures, and processes to ensure products and services comply with regulatory standards, specifications and corporate procedures. Manages product and service quality planning, evaluation, process control, records, and document changes. Works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services. Responsible to manage their direct reports and staff to achieve quality goals and maintain regulatory compliance. Woks with multiple QMS systems for data and record management to maintain regulatory compliance. Coordinate and lead actions for regulatory, customer and corporate audits and customer technical visits. Responsible for engaging and working with Operations, Maintenance and Engineering to achieve site savings goals. Defect Training - Visual Aids.
Qualifications 4-8 years of experience, preferred Bachelor's degree in related field, preferred or equivalent work experience, Knowledge with quality system regulations ISO 13485 and FDA, and document control, preferred Experience in Internal Audits, preferred Participation in CAPA System, preferred Knowledge Quality system Regulations ISO 13485 and FDA, preferred Knowledge Document Control, preferred
Coordinates and supervises the daily activities of operations or business staff Administers and exercises policies and procedures Ensures employees operate within guidelines Decisions have a direct impact to work unit operations and customers Frequently interacts with subordinates, customers, and peer groups at various management levels Interactions normally involve information exchange and basic problem resolution
Anticipated salary range: $71,400 - $102,000 annually Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Application window anticipated to close: 10/16/2026.
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 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 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. To read and review this privacy notice click here
Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges - now, and in the future. View Cardinal Health on YouTube