Senior Quality Engineer

Cardinal Health Chicopee , MA 01014

Posted 3 months ago

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.

Accountabilities:

  • Actively participate in the quality engineering functions within the manufacturing facility by assisting in developing, implementing and administering quality specifications, test methodologies, and sampling plans for product and process.

  • Working 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.

  • 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.

  • Maintain primary responsibility for critical quality systems including the internal audit program, CAPA system, and control of non-conforming product.

  • Assure overall regulatory compliance to the QSR and applicable Quality System standards. Manage internal audit program including conducting quality audits. Develop corrective and preventive actions for internal audits, assist with calibration activities.

  • Perform supplier audits and initiate/monitor follow up actions as required, manage SCAR program, initiate SCARs, and track SCAR due dates

  • Manage all aspects of CAPA program; ensure dates are met, determine root cause/corrective and/or preventive actions necessary and mentor team members on successful implementation.

  • Manage quality improvement projects including collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs

  • Develop specifications and test methods to meet customer, product and internal quality requirement, risk assessment and failure mode effects analysis by us of statistical tools to perform analysis and data trending

  • Review new and modified product designs and processes for quality compliance.

  • Serves as back-up Quality Manager duties in absence of Quality Manager attendance

Qualifications

  • Bachelors in related field, or equivalent work experience, preferred

  • 2+ years' experience in manufacturing facility or related field, preferred

  • Six Sigma Training/Lean Manufacturing Training Agile, BPCS, Microsoft Office, preferred

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

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


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Senior Quality Engineer

Cardinal Health