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Sr Quality, Engineer Job

Remote Eligible:  Hybrid
Onsite Locations(s): 

Heredia, CR

Additional Locations:  N/A

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

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 or testing equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
  • Document investigation findings.
  • 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:

  • Licenciature Degree in Chemical, Industrial, Electronic, Mechanical, Biotechnology, Electromechanical Engineering or Related Field.
  • 5+ years of experience
  • English level B2+ (80-89%)
  • Knowledge on QSR’s , ASQ Certified , Six Sigma APQP or similar tools.
  • Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods
  • Knowledge in product development process and transfer of new products is a plus.
  • Desirable ASQ Certified
  • Knowledge of Six Sigma, Lean, APQP or similar tools
  • Experience in FDA regulated industry or ISO certified organization
  • Knowledge in Quality Systems
  • Experience in quality assurance, quality engineering or related functions in a FDA regulated industry or ISO certified organization, is required
  • Knowledge of QSRs
  • Travel available  to support product/process development activities or product transfer might be required.

Benefits • Life-Work Integration • Community • 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.

Job Segment: Quality Engineer, Biotech, Senior Quality Engineer, Manufacturing Engineer, Engineering, Quality, Science

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