Sr. Quality Engineer
Greenwood, IN - USA
Job Summary
What Quality Engineering contributes to Cardinal Health
Quality 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.
Demonstrates understanding of quality philosophies principles systems methods tools and standards.
Demonstrates understanding of the audit process including types of audits planning preparation execution reporting results and follow-up.
Develops and implements quality programs including tracking analyzing reporting and problem solving.
Plans controls and assures product and process quality in accordance with quality principles which include planning processes design control material control acceptance sampling and measurement systems.
Demonstrates knowledge of reliability maintainability and risk management including key terms and definitions modeling systems design assessment tools and reporting.
Applies problem solving and quality improvement tools and techniques including preventative and corrective actions and how to overcome barriers to quality improvements.
Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.
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 Greenwoods Quality System
Solid 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 programs
Support 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 preferred
2 years experience in related field preferred
Green belt white belt black belt certifications a plus
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 actions to resolve
Applies judgment within defined parameters
Receives general guidance may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy
Anticipated salary range:$59600 - $85100
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: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 candidates geographical location relevant education experience and skills and an evaluation of internal pay equity.
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Candidates who are back-to-work people with disabilities without a college degree and Veterans are encouraged to apply.
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.
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Required Experience:
Senior IC
About Company
Cardinal Health improves the cost-effectiveness of healthcare. We help focus on patient care while reducing costs, enhancing efficiency and improving quality.