Quality Engineer

hace 4 días

Alajuela, Costa Rica Freudenberg Medical srl. A tiempo completo

Freudenberg es un grupo tecnológico global que fortalece a sus clientes y a la sociedad a largo plazo mediante innovaciones orientadas al futuro. En colaboración con nuestros socios, clientes y la comunidad científica, desarrollamos tecnologías de vanguardia, así como productos, soluciones y servicios de calidad óptima para 40 segmentos del mercado. El Grupo Freudenberg emplea a aproximadamente 50.000 personas en 60 países de todo el mundo y genera unas ventas de más de 10 mil millones de euros.

En Freudenberg Medical, fabricamos productos que salvan y mejoran la vida de las personas todos los días, en todo el mundo. Somos un proveedor global de diseño y fabricación de dispositivos médicos con 11 sedes en todo el mundo y más de 2.000 empleados. La innovación es el alma de nuestra empresa y estamos orgullosos de nuestra calidad líder en la industria, la fabricación Lean y el enfoque en la innovación en productos y tecnologías de procesamiento. Freudenberg Medical es un lugar emocionante para trabajar con muchas oportunidades para aprender, desarrollar y hacer crecer su carrera. Únase a nosotros y juntos marcaremos una diferencia en el futuro de la atención médica.

**Responsabilidades**:

- Responsible for the elaboration of quality inspection procedures, test methods, quality plans, inspection forms, or any other documentation required.
- Coordinate and carry out qualification and validation activities for new products, processes, test methods, changes and transfers as per FDA regulations (IQ, TMV, OQ, PQ and Quality Plans).
- Prepare and review validation protocols and reports for moderate and high complexity qualifications or participate in the approval of them.
- Prepare and review validation strategies against quality system regulation and support or lead the execution of validation plans for assigned quality projects. Participate and lead communications with the customers including weekly sustaining or NPI report out meetings, QBRs, projects meetings, other.
- Assess compliance with applicable regulations within the manufacturing processes and recommend improvements to ensure that safe and effective products are produced.
- Executes investigations for audit non-conformances, complaints and Corrective and Preventive Actions (CAPA) to correct a problem presented in the quality system or the manufacturing process.
- Responsible for the elaboration of risk management documentation such as Risk Management Plan / Report and Process FMEAs.
- Become supervisor of Quality Inspectors and/or Technicians and be responsible for the task’s assignment / coordination of this personnel in charge.
- Train Quality Assurance Inspectors and manufacturing personnel in understanding of procedures, specifications, environmental controls, etc.

Titulo/ Diplomas
- Bachelor's Degree in Engineering, or related science/technical field.
- Bilingual (English / Spanish) 90-100% desired.
- At least 4 years related experience and/or training working knowledge of 21CFR820 (quality systems regulation/good manufacturing practices for medical devices), ISO 13485 and 14971 standards.
- At least 2 years’ experience leading and/or supporting NPI projects
- Requires excellent organizational, communications and project management skills and the ability to work effectively in a multi-task environment. Projects manage tactical day to day activities along with higher level projects.
- Understanding and technical leadership and guidance with statistical techniques (i.e. sample size determination, DOE, Lean and Six Sigma process improvement techniques, etc.)
- Strong knowledge and understanding of quality requirements for the Medical Device Industry with general technical understanding of business operations.
- Excellent verbal, written, analytical, computer and interpersonal skills with the ability to demonstrate lead capabilities with team approach, and sound decision making.
- Assertive, Takes initiative, self-starter, energetic, motivated and self-managed.
- Positive, Respectful, and Professional attitude.
- American Society for Quality CQE (Certified Quality Engineer) preferred but not required.
- Experience with injection molding, silicone, and coating preferred

Algunos de sus beneficios

Apoyos para educación: Ayuda financiera para ayudar a impulsar tu carrera al siguiente nível

Diversidad e Inclusión: Ingresa a un mundo de innovación impulsado por la diversidad

Sustentabilidad/Servicio comunitario: Haciendo la diferencia con sustentabilidad, servicio comunitario

Subsídio de comedor: Subsídio que hace las comidas mas accesibles

Seguro de gastos médicos mayores: Seguro: protección de respaldo contra riesgos para la salud

Información adicional

Roy Vargas
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