Quality Engineer
Cardinal Health
Alajuela, Alajuela
hace 5 días

What Quality Engineering contributes to Cardinal Health

Summary :

Responsible for the review, approval, coordinate and plan validations and projects in order to assure product meets company policies and customer requirements.

Evaluate the effectiveness of the validation process towards established requirements and develop a team approach for addressing any deficiencies.

Identify, evaluate and execute opportunities for continuous improvement consistently. Work with other departments to ensure projects and validations are executed without delays.

Essential Functions :

  • Develop, perform (if required) and summarize qualification and validation protocols per internal procedures, regulatory expectations, industry standards and product / process requirements.
  • Provide expertise and guidance to the engineering and manufacturing team regarding projects implementation
  • Involvement in the manufacturing process to ensure that projects follow the best validation and implementation
  • Participate in risk management process for new and change process.
  • Education : - B.S Degree in a Scientific, Engineering or Management discipline. Experience : -Requires excellent computer skills, proficiency in MS Office suite, and Minitab.

  • Minimum of three years’ experience in a regulated manufacturing environment, in particular Medical Device Industry.- Preferred : Four years Quality Assurance experience in medical device and / or pharmaceutical manufacturing environment.
  • Sterilization experience is a plus.- Must be able to speak, read and write in the English language. - Skilled in quality plan development and statistical methods.

  • Skilled in root cause analysis and failure investigation. 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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