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Purpose:
Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of the highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure the development of the highest quality new products.
Key Responsibilities:
1. Learns to 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 the process owner to bound product stops and document release criteria.
2. Gains 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.
3. Learns Process Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
4. 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.
5. Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
6. Responsible for the final Process Monitor Release for products prior to distribution.
Education & Experience:
1. Minimum of Bachelor of Science Degree in Engineering/Technology.
2. 2-3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
3. Experience in the medical device industry is an advantage.
4. Experience on an automated/high volume line is an advantage.
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