Cardinal Health Hazelwood , MO 63042
Job Description: SummaryDemonstrates 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.
Represents the QA function as a core team member on cross-functional teams supporting MDD/MDR remediation projects.
Assesses overall product risk by facilitating the development of risk management tools such as fault tree analysis, failure mode and effects analyses (FMEAs), failure mode, effect and criticality analysis (FMECAs) and contributes to the completion of the overall product risk management file
Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required
Contributes to the successful completion of Process Validation initiatives by facilitating validation master plans and the qualification activities required to meet validation requirements
Completes risk analysis studies per ISO 14971:2012 standards & risk management procedures.
Job requires interactions with project team members as well as members of the Quality extended team
Tracking timelines and facilitating the required Quality Engineering tool
Assisting with projects and assuring proper and consistent implementation of the quality engineering tools
Bachelors in related field, or equivalent work experience, preferred
3+ years experience in related field, preferred
Experienced in 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR and the Medical Device Directive.
Trained in Risk Manangement, ISO 14971:2012, HA, IIA, Design FMEA, Process FMEA, Use FMEA.
Understanding of CAPA systems & Investigation techniques.
Well-versed in comparative Statistical techniques & sampling plans.
Previous experience working in a cross-functional team environment preferred
ASQ CQE, CQA, CSQE and/or CRE certification is a plus
Familiar with statistical software tools (Minitab, Stat Graphics, Statistica),
Familiar with IEC 60601 and product specific industry standards.
DFSS / Lean Green Belt or Black Belt is a plus
What is expected of you and others at this level
Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
May contribute to the development of policies and procedures
Works on complex projects of large scope
Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
Completes work independently receives general guidance on new projects
Work reviewed for purpose of meeting objectives
May act as a mentor to less experienced colleagues
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.