Senior Quality Assurance Engineer

hace 1 semana


Paraíso, Paraíso, Costa Rica Boston Scientific Corporation A tiempo completo

At Boston Scientific Corporation, we are seeking a highly motivated and detail-oriented Senior Quality Assurance Engineer to join our team.

About the Role:

The Senior Quality Assurance Engineer will provide process/quality engineering support to manufacturing or new product development teams, ensuring delivery of high-quality products to customers.

Your Responsibilities Include:

  • Identifying manufacturing process defects and assisting in identifying primary root causes.
  • Understanding product quality plans, documents, and systems by reviewing product specifications and quality specifications.
  • Becoming familiar with product/process improvement efforts by understanding current quality metric data.
  • Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
  • Checking and providing support in the execution and investigation of CAPAs, NCEPs, Failure Mode Investigations, etc.
  • Evaluating new equipment and processes and participating in the transfer of new products.
  • Getting involved 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.
  • Reading and interpreting technical drawings, procedures, and protocols.
  • Assuring that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
  • Documenting investigation findings in analysis report on GCS2.
  • Becoming a trainer for the Software related with complaints handling process (GCS2), as required.
  • Working 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.
  • Supporting other functional areas during the validation activities.
  • Providing 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.
  • Clarifying priorities and removing 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's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related field.
  • English Level required: B2:(60-70%).
  • 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 capability).
  • 1 year or more in current position.
  • Annual Performance evaluation rating


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