Purpose and Passion
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 :
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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 :
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.
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're Looking For :
Bachelor degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related field.
English Level required : B2 (70% - 79%)
Desired knowledge :
ASQ Certification (CQE,SSGB)desired.
Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods.
Scientific tools (e.g Gage R&R, DOE, process).
At least 2 years of experience in similar position.
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.
Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran