Sr. Quality Engineer

Cardinal Health; Greenwood, Northern (IN, KY); Hybrid; USD 60,000 - 85,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account

401k savings plan

Access to wages before pay day with my

Flexible spending accounts

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health Quality Engineering is responsible for planning, evaluating, and controlling product and service quality across development and manufacturing.

The team applies prevention-based methods, analyzes data, and supports improvements to meet regulatory standards.

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

Responsibilities

• Observe safety precautions and report hazards.
• Provide quality engineering support in new product development.
• Review designs for safety, testability, reliability and manufacturability.
• Perform product risk assessment and FMEA; create verification/validation test plans.
• Conduct quality audits and implement preventive actions (CAPA).
• Investigate customer complaints and determine disposition of nonconforming products.

Skills

Quality engineering

Statistical analysis

FMEA

Root cause analysis

Problem solving

Education

Bachelor's degree in related field

Job description

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 Greenwood’s 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: $59,600 - $85,100 Bonus eligible: No

Benefits:

• 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

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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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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.

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