Sr. Quality Engineer
Cardinal Health
Quality Engineering PositionQuality Engineering is responsible for product and service quality planning, evaluation and control. Works cross-functionally in the development and implementation of prevention based methodologies used in design, manufacturer, test, sustainability and correction of products and services.Responsibilities:Observe all safety precautions and regulations at all times in all areas where duties are performed. Responsible for reporting all safety hazards and potential unsafe working conditions.Responsible for seeing that all tasks are performed in a manner that complies with Greenwood's Quality SystemSolid base knowledge of the Quality System Regulation (CFR 820)Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer and internal audits as required.Conduct GMP training for all new hires as part of their orientation. Provide refresher training as needed for all employees.Provide quality engineering support in new product development.Review new and modified product designs for safety, testability, reliability, serviceability, and manufacturability.Perform product risk assessment and failure mode effects analysis (FMEA).Create verification and validation test plans and conduct prototype testing and analysis for reliability, standards compliance, and product requirements compliance.Perform statistical analysis of test results.Conduct quality audits and develop subsequent preventive action programsSupport the nonconforming product and material on hold systems, including placing product on electronic hold, reviewing and revising expiration dates as necessary and facilitating Material Review Boards to determine disposition of nonconforming products.Investigate and respond to customer complaints, including facilitating Material Review Boards to determine disposition of nonconforming product.Determine root cause/corrective and/or preventive action for material on hold, customer complaints, externally generated Supplier Corrective Actions (SCARs) and CAPAs.Evaluate internally generated CAPAs for root cause and effective corrective actions.Update/revise product plans of control and other site documentation where necessary.Maintain and evaluate sampling plans.Process Corporate Holds.Assist in process improvements as related to improved quality and yields.In conjunction with R&D, Operations, OPEX, and Sales and Marketing, develop specifications and test methods to meet customer, product and internal quality requirements. This may include writing procedures to carry out requirements.Approve change notices (CNs).Qualifications:Bachelors in related field, or equivalent work experience, preferred2+ years' experience in related field, preferredGreen belt, white belt, black belt certifications a plusWhat is expected of you and others at this level:Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasksWorks on projects of moderate scope and complexityIdentifies possible solutions to a variety of technical problems and takes actions to resolveApplies judgment within defined parametersReceives general guidance may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracyAnticipated salary range: $59,600 - $85,100Bonus eligible: NoBenefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication window anticipated to close: 9/18/2026 *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 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.
$59.6k - $85.1k
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