Ingeniero de Calidad

at  Cardinal Health

SUMMARY OF POSITION

Participates in the quality engineering functions within the manufacturing Focus Factory by assisting in developing, implementing and administering quality specifications, test methodologies, and sampling plans for product and process. Works directly with Manufacturing, R&D and Engineering to assure quality considerations are adequately covered in the design, testing, and release of materials, components and completed products. Position is expected to provide quality-engineering expertise for the continuous improvement of product and process and provide engineering input for corrective and preventative action for in-house and customer reported problems. Participation in internal audits, and assessments by external parties is expected. Position is expected to function as a problem solver, capable of analyzing problems and implementing root cause elimination solutions. Position maintains primary focus factory responsibility for critical quality systems including the internal audit program, CAPA system, and control of non-conforming product. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards.

EDUCATION

Bachelor’s degree preferred and/or equivalent experience
.

EXPERIENCE

Minimum three years in engineering or QA preferred. MDD and CMDR experience preferred.

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.

SUMMARY OF POSITION

Participates in the quality engineering functions within the manufacturing Focus Factory by assisting in developing, implementing and administering quality specifications, test methodologies, and sampling plans for product and process. Works directly with Manufacturing, R&D and Engineering to assure quality considerations are adequately covered in the design, testing, and release of materials, components and completed products. Position is expected to provide quality-engineering expertise for the continuous improvement of product and process and provide engineering input for corrective and preventative action for in-house and customer reported problems. Participation in internal audits, and assessments by external parties is expected. Position is expected to function as a problem solver, capable of analyzing problems and implementing root cause elimination solutions. Position maintains primary focus factory responsibility for critical quality systems including the internal audit program, CAPA system, and control of non-conforming product. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards.

EDUCATION

Bachelor’s degree preferred and/or equivalent experience
.

EXPERIENCE

Minimum three years in engineering or QA preferred. MDD and CMDR experience preferred.

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.

ESSENTIAL FUNCTIONS

• Responsible for seeing that all tasks are performed in a manner that complies with focus factory facility policies. Support Quality Assurance System.
• Develop subsequent corrective/preventive actions for internal audits.
• Documentation as required, including processing engineering change request.
• QA system training. Metrics reporting. Knowledge of applicable regulatory standards.
• Perform validation studies as required.
• Provide input to validations. Participates in CAPA Program.
• Determine root cause/corrective and/or preventive actions for CAPAs.
• Assist in calibration activities and investigations.
• Participate in customer complaint investigations.
• Initiate and process Corporate holds and deviations.
• Initiate and process internal deviations.
• 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).
• QA Improvement Training (SPC, Five-Why, FDA etc).
• 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.
• Facility Sterilization/Environmental Monitoring, as required.

ESSENTIAL FUNCTIONS

• Responsible for seeing that all tasks are performed in a manner that complies with focus factory facility policies. Support Quality Assurance System.
• Develop subsequent corrective/preventive actions for internal audits.
• Documentation as required, including processing engineering change request.
• QA system training. Metrics reporting. Knowledge of applicable regulatory standards.
• Perform validation studies as required.
• Provide input to validations. Participates in CAPA Program.
• Determine root cause/corrective and/or preventive actions for CAPAs.
• Assist in calibration activities and investigations.
• Participate in customer complaint investigations.
• Initiate and process Corporate holds and deviations.
• Initiate and process internal deviations.
• 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).
• QA Improvement Training (SPC, Five-Why, FDA etc).
• 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.
• Facility Sterilization/Environmental Monitoring, as required.