AdditionalLocations : Purpose and Passion
Purpose and Passion
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.
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.
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