Senior Quality Assurance Engineer
hace 1 semana
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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