Reliability Design Quality Engineer

Cardinal Health Hazelwood , MO 63042

Posted 3 months ago

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.

Accountabilities

  • 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

Qualifications

  • 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.


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manager Design Quality Engineering

Cardinal Health

Posted 1 week ago

VIEW JOBS 11/9/2018 12:00:00 AM 2019-02-07T00:00 What QRA Management contributes to Cardinal Health QRA Management is responsible for strategic oversight and leadership direction over multiple job families or areas of expertise within the QRA function. The Design Quality Engineering Manager will have oversight and responsibility for the Quality Engineering functions for the launch of new medical devices and changes to existing medication devices. Accountibilities * Oversee the Design Quality Engineering Function for CAH owned Medical Devices. Works with R&D Engineering, Marketing, Operations and Regulatory for launching new devices and changes made to existing devices. * Oversees the design quality engineering functions * Risk management ownership * Design control documentation and sits on the design review committee for projects * supporting post market surveillance (assisting in complaint data analysis and trending and CAPA's) * Work with production on designs and day to day questions on design changes and support Qualifications * Bachelors Degree in Engineering (Mechanical or Electrical) * 8+ years experience in related field, preferred * Medical Device industry experience & Quality Engineering * Risk Management experience * Design Control experience What is expected of you and others at this level * Manages department operations and supervises professional employees, frontline supervisors and/or business support staff * Participates in the development of policies and procedures to achieve specific goals * Ensures employees operate within guidelines * Decisions have a short term impact on work processes, outcomes, and customers * Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management * Interactions normally involves resolution of issues related to operations and/or projects * Gains consensus from various parties involved 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. Cardinal Health Hazelwood MO

Reliability Design Quality Engineer

Cardinal Health