Quality Assurance Manufacturing

Be part of Stefanini!

At Stefanini, we are more than 30,000 geniuses, connected from 41 countries, doing what they are passionate about and co-creating a better future.

1. Provides leadership and oversight for the development and coordination of the quality and regulatory strategy for the site.
2. Oversees product development compliance. Responds to regulatory issues concerning products and business processes.
3. Participates in special projects and initiatives, as requested.
4. Manages customer complaint process, including review, trending, and internal / external customer feedback.
5. Reviews and define business critical operating measures, and assures that any noncompliance associated with manufacturing processes, audit findings, complaints, design processes, etc. are addressed in a timely manner and that appropriate corrective and preventive actions are taken.
6. Assure quality metrics for the assigned area.
7. Prepares reports by collecting, analyzing and summarizing data.
8. Ensures products adhere to company and regulatory quality standards.
9. Responsible for development of Inspection and work instructions.
10. Respect of Ethics and Data Privacy requirements
11. Responsible to coordinate inspection and testing products.
12. Managing NCMR´s,NCR´s,CAPA´s related with assigned area.

• Bachelors of Science in Engineering or other related technical field.
• Five (5) to 10 years in a Manufacturing, Quality Assurance, and/or Engineering role, with a minimum of 5 years in Manufacturing and/or Quality
• Experience in the medical device industry or automotive industry in development and deployment on Quality System and process controls and continuous improvement methods (QSR’s, ISO9000/QS9000, ISO13485)
• Primary/Secondary party compliance auditing experience.
• Excellent communication/interpersonal skills (fluent in Spanish and English languages).
• Computer knowledge in programs such as Word, Excel, PowerPoint, Agile and JD Edwards
• Practical experience in metrology, test, inspection and analysis techniques

Somos una empresa global con 35 años de experiencia en el mercado, ofrecemos una sólida selección de servicios como: automatización, nube, Internet de las cosas (IoT) y experiencia de usuario (UX).

Creemos que la tecnología puede revolucionar una empresa y la innovación es fundamental para fomentar el desarrollo y la competitividad. También valoramos las nuevas ideas y el poder de una mente abierta, por lo que reconocemos que cada talento es esencial para la calidad de nuestros proyectos y especialmente para nuestro progreso.

Mantenemos nuestra excelencia invirtiendo en innovaciones tecnológicas, las mejores alianzas, adquisiciones de empresas en todo el mundo y la contratación de profesionales altamente capacitados.