Manufacturing Quality Specialist
hace 7 días
**About Boston Scientific Corporation**
Boston Scientific is a global medical technology leader, dedicated to advancing science for life. We provide innovative solutions that improve the health and quality of life of millions of people around the world.
**Quality Engineer Ii Heredia Turno B Job Summary**
We are seeking a highly motivated and detail-oriented Manufacturing Quality Specialist to join our team in Heredia, Costa Rica. As a key member of our manufacturing operations, you will be responsible for ensuring the highest quality products meet customer requirements.
**Responsibilities**
- 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.
- 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.
- Understand product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems.
- Become 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.
- Check and provide support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
- Evaluate new equipment and processes and participates in the transfer of new products.
- Get 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.
- 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.
**Requirements**
- Bachelor or Licenciature degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
- English Level desired: 70-79%.
- Experience: At least 2 years.
- Desired knowledge: ASQ certification (CQE, SSGB) desired, Problem Solving, Knowledge of QSR's, Formal training on statistical and quality techniques desirable, Networking.
- Please submit Resume in English.
**What We Offer**
We offer a competitive salary range of $60,000 - $80,000 per year, depending on experience, plus benefits, career growth opportunities, and a collaborative culture driven by innovation and caring for human life.
**How to Apply**
If you're passionate about delivering high-quality products and improving patient lives, we encourage you to apply for this exciting opportunity.
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