Quality Engineer II
Boston Scientific
Heredia, H, CR, 0
hace 9 días

About the role :

  • Provide Process / Quality Engineering support to manufacturing or new product development teams, helping to ensure delivery of highest quality product or new products to the customer.
  • Your Responsibilities are :

  • May execute the following resposibilities :
  • Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions.
  • May be responsible for working with process owner to bound product stops and document release criteria.

  • Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems.
  • May be responsible for learning risk analyses and FMEAs.

  • Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
  • Becomes familiar with Product / Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development
  • Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
  • Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
  • Evaluates new equipment and processes and participates in the transfer of new products.
  • Evaluates new equipment and processes and participates in the transfer of new products.
  • Get involve in various stages of equipment and processes validations : Run and / or review and / or approve reports I.
  • Q 's, O.Q' s and P.Q 's as well as any other document relating to validation.

  • Read and interpret technical drawings, procedures, and protocols
  • Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
  • Document investigation findings in analysis report on GCS2
  • Become a trainer for the Software related with complaints handling process (GCS2), as required.
  • Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components
  • Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
  • What We’re Looking For :

  • Bachelors Degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
  • 3+ years of experience
  • English level B2+ (80-89%)
  • Knowledge on QSR’s , ASQ Certified , Six Sigma APQP or similar tools (Desirable).
  • Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods
  • Availability to work on afternoon shift ( Monday-Friday 3 : 30pm to 10 : 00pm / Saturday 7 : 00am to 2 : 30pm)
  • About us

    As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE : BSX) is to transform lives through innovative medical solutions that improve the health of patients.

    If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

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