Descripción y detalle de las actividades
The Quality Engineer is responsible for compliance to procedures and regulations for Manufacturing Controls compliance with 21 CFR 820, ISO 13485, ISO 14971, ISO 14644, MDSAP and MDR.
Provides status reporting regarding manufacturing processes deliverables, dependencies, risks and issues, communicating across teams and to direct management.
Assists in managing all Manufacturing Quality Assurance
aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives.
Supports 3rd party audits regarding manufacturing processes and policies.
Identification and interpretation of recognized standards for medical manufacturing (e.g. ISO 13485, 21 CFR 820, ISO 14644, etc.).
Assists for various testing planning, execution and reporting, IQ, OQ, PQ. Verification and Validation of manufacturing processes, equipment and tooling etc.
Participates in the investigations and dispositions of product, non-conformances and changes, CAPA, NC, MRB.
QA representative on cross functional teams, GEMBA walks,
Manufacturing Kaizen Events (when applicable).
Ensure compliance with environmental requirements per ISO
14644 and related monitoring.
Elaborate Validation plan and reports.




Participate as lead auditor/team member during internal audit.
Experiência y requisitos
B.S. in Engineering or related technical discipline.
Language: English 85% written & Conversational
Visa B1 / B2 to travel to USA
Training in some or all of the following:
- ISO 13485:2016, ISO 14644 and ISO 17025
- Six-Sigma.
- Lean Principles
- Solid knowledge of relevant regulations and guidance related to design assurance.
- Proven ability to work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence.
- Demonstrated technical communication skills (both written
and oral).
- Proficient in Microsoft Office suite, Minitab or equivalent
statistical software Desirable
- Proactive and self directed
Beneficios
- Beneficios de acuerdo a la LFT
- fondo de ahorro
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Jornada completa
- Turno Matutino
- Lunes a viernes
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Edad** 18 - 65 años
**Disponibilidad p. viajar** Si

📌 Quality Engineer (Mexicali)
🏢 Empresa reconocida
📍 Mexicali