Engineer II, Quality
Boston Scientific
Coyol, A, CR
hace 7 días
source : Successfactors

AdditionalLocations : Purpose and Passion

Purpose and Passion

  • ComprehensiveBenefits
  • Life-Work Integration
  • CareerGrowth
  • At Boston Scientific, you will find acollaborative culture driven by a passion for innovation that keepsus connected on the most essential level.

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

    Together, we’reone global team committed to making a difference in people’s livesaround the world. This is a place where you can find a career withmeaningful purpose improving lives through your life’swork.

    Aboutthe Role :

    ProvideProcess / Quality Engineering support to manufacturing or new productdevelopment teams, helping to ensure delivery of highest qualityproduct or new products to thecustomer.

    YourResponsibilitiesInclude :

  • May executethe following resposibilities : Identify Manufacturing processdefects (scrap, nonconforming material, customer complaints) bydispositioning non-
  • conforming material, assisting in identificationof primary root causes and understanding corrective andpreventative actions.

    May be responsible for working with processowner to bound product stops and document releasecriteria.

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

  • Monitoring Systems by becoming familiarwith systems applications and critical process steps; and throughfamiliarization with methods used to reduce processvariation.
  • Becomes familiar withProduct / Process improvement efforts by understanding currentquality metric data and learning the various analysis methods usedto enhance sustaining product design and new productdevelopment
  • Learns Quality Tools &Training Materials by gaining knowledge of prevalent tools used andby reviewing & utilizing available trainingmaterials.
  • Checks and provides support in theexecution and investigation of CAPAs, NCEP, Failure ModeInvestigations, etc.
  • Evaluates new equipmentand processes and participates in the transfer of newproducts.
  • Get involve in various stages ofequipment and processes validations : Run and / or review and / orapprove reports I.Q 's, O.
  • Q' s and P.Q 'sas well as any other document relating tovalidation.

  • Read and interpret technicaldrawings, procedures, and protocols
  • Assure thatall laboratory equipment is in compliance to perform the analysisactivities (calibration, safety,cleanness).
  • Document investigation findings inanalysis report on GCS2
  • Become a trainer forthe Software related with complaints handling process (GCS2), asrequired.
  • Work with Research and Development toefficiently qualify new components; assist suppliers in creating ofstatistical sampling plans, inspection methodology and qualityprocedures for new components
  • Responsible forreviewing and developing process validation protocols and reports.Support other functional areas during the validationactivities
  • Provide supervision, leadership, andoverall direction to the Quality Release team to ensure they areidentifying issues, quarantining defective product, and efficientlymoving product through the release process.
  • Clarifypriorities and remove roadblocks to maintain a high level ofquality in accordance with ISO standards, cGMP's, Corporateand site level SOP's.

    WhatWe’re Looking For :

  • Bachelor'sdegree in Chemical, Industrial, Electronic, Biotechnology,Electromechanical Engineering or relatedField.
  • English Level required : B2 : (70-79%).
  • Desired knowledge : ASQcertification (CQE, SSGB) desired, Formal studies in process& product validation is desired as well as thoroughunderstanding of inspection techniques and statistical methods,Scientific tools (e.
  • g. Gage R&R, DOE, processcapability.

  • At least 2 years of experience insimilarposition.
  • About us

    As a globalmedical technology leader for more than 35 years, our mission atBoston Scientific (NYSE : BSX) is to transform lives throughinnovative medical solutions that improve the health of patients.

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

    RequisitionID : 442340

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