Engineer II Quality Coyol

at  Boston Scientific Corporation

Job Description

ABOUT THE ROLE:

Provide Process/Quality Engineering support to manufacturing teams, helping to ensure delivery of highest quality product 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.
Work on preventive quality initiatives through vulnerability identification and implementation of improvement ideas that will reduce non conformances.
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.