Quality Engineer II (B Shift) Job
Boston Scientific
Heredia, H, CR
hace 2 días
source : Successfactors

AdditionalLocations : Purpose and Passion

Purpose and Passion

  • Comprehensive Benefits
  • Life-Work Integration
  • Career Growth
  • At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level.

    With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges.

    Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life’s work.

    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 include :

  • 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.
  • 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
  • Provide supervision, leadership, and overall direction to the Quality Release team to ensure they are identifying issues, quarantining defective product, and efficiently moving product through the release process.
  • Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, cGMP's, Corporate and site level SOP's.

    What we are looking for (requirements) :

  • English level : 80%
  • Academic background : Chemical, Industrial, Electronic, Biotechnology, or Electromechanical Engineering.
  • Soft Skills : Execution, Quality oriented, Planning.
  • Desirable : Statistical skills, ASQ Certified, Knowledge of Six Sigma and Lean Manufacturing.
  • Experience : 2 years or more.
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    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 include :

  • 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.
  • 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
  • Provide supervision, leadership, and overall direction to the Quality Release team to ensure they are identifying issues, quarantining defective product, and efficiently moving product through the release process.
  • Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, cGMP's, Corporate and site level SOP's.

    What we are looking for (requirements) :

  • English level : 80%
  • Academic background : Chemical, Industrial, Electronic, Biotechnology, or Electromechanical Engineering.
  • Soft Skills : Execution, Quality oriented, Planning.
  • Desirable : Statistical skills, ASQ Certified, Knowledge of Six Sigma and Lean Manufacturing.
  • Experience : 2 years or more.
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  • 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.

    Requisition ID : 435189

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