Sr. Quality Engineer
Boston Scientific · Cartago
Description du poste
About the role
We are looking for a Senior Quality Engineer to provide process and quality engineering support to manufacturing and new product development teams. The role ensures the delivery of high‑quality products by identifying defects, driving corrective actions, and supporting validation activities.
Key responsibilities
- Identify and disposition manufacturing defects, analyze root causes, and implement corrective and preventive actions.
- Review product and quality specifications, conduct risk analyses and FMEAs, and support quality plans.
- Monitor critical process steps, reduce variation, and contribute to continuous improvement initiatives.
- Participate in equipment and process validation, including IQ, OQ, and PQ documentation.
- Assist in the transfer of new products, evaluate new equipment, and develop statistical sampling and inspection methods.
- Document investigations, generate analysis reports in GCS2, and provide training on complaint handling software.
- Collaborate with R&D and suppliers to qualify components and establish quality procedures.
Required profile
- Bachelor’s degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or a related field.
- English proficiency at B2+ level.
- ASQ certification (CQE, SSGB) or similar quality certifications are a plus.
Required skills
- FMEA and risk analysis.
- CAPA and NCEP investigation.
- Six Sigma and APQP methodologies.
- Process validation (IQ, OQ, PQ) and statistical sampling.
- Use of GCS2 software for complaint handling.
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Boston Scientific
Cartago