**SUMMARY OF POSITION**
The position requires knowledge in the implementation of projects that generate a continuous improvement of the already established processes. Execute tasks related to contract maufacturing, as well as information and communication management in contract manufacturing functions. Assist the manufacturing engineering team in the implementation of projects.
**ESSENTIAL FUNCTIONS**
- Responsible for seeing that all tasks are performed in a manner that complies with focus factory facility policies. Support Quality Assurance System.
- Documentation as required, including processing engineering change request.
- Perform validation studies as required.
- Provide input and execute validations activities.
- Determine root cause/corrective and/or preventive actions for CAPAs.
- Manage Calibration Program, as required.
- Six Sigma/Lean/Cost Savings Support.
- Manage and/or participate on quality improvement projects including collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs.
- Support cost savings projects. Use of statistical tools to perform analysis and data trending.
- Perform process risk assessment and failure mode effects analysis (PFMEA).
- Develop specifications and test methods to meet customer, product and internal quality requirements. This may include writing procedures to carry out requirements.
- Review new and modified product designs and processes for quality compliance.
- Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer, and internal audits as required. Production Floor Support/Continuous Improvement Initiatives.
- Support focus factory core teams. Support resolution of production floor issues including aiding in problem solving. Support Quality Improvement Teams (lead and participate).
- Support SPC program in assigned focus factory areas.
- Maintain and evaluate sampling plans.
- Update/revise product control plans, inspection and test standards, and other site documentation where necessary. Support on QIP project.
**REQUIREMENTS**
**_ Education_**
Bachelor's degree preferred and/or equivalent experience.
**_ Experience_**
Minimum 2 years in engineering or QA preferred. MDD and CMDR experience preferred.
Experience in Validation Activities (TMV, IQ, OQ, PQ)
**_ Preferred Qualifications_**
FDA Regulated Industry experience as well as applicable Quality System Standards and Regulations experience.
Project Management, SPC, DOE, FMEA.
Six Sigma Training/Lean Manufacturing Training.
**_ Preferred Competencies_**
Dealing with Ambiguity, Creativity, Customer Focus, Timely Decision Making, Decision Quality, Functional/Technical Skills, Innovation Management, Intellectual Horsepower, Learning on the Fly, Listening, Managing and Measuring Work, Organizing, Perseverance, Planning, Priority Setting, Problem Solving, Process Management, Drive for Results, Managing Through Systems, Technical Learning, Total Work Systems (e.g. TQM/ISO/Six Sigma), Written Communications.
- 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._