Descripción y detalle de las actividades
Job Purpose Summary Responsible for developing strategies and initiatives for maintaining the CAPA and Audit Quality Programs aligned with medical devices Regulations, Standards Requirements and Company goals and objectives. Primary responsibility is to maintain the activities related to CAPA and Audit Quality Programs. This position has knowledge and experience of working in regulated environments (i.e. ISO 13485, 21 CFR Part 820, 21 CFR Part 11) and sufficient knowledge and experience using an electronic Quality system. What we value Customer First: We deliver extraordinary experiences. Accountability: We do what we say Integrity: We do what is right Inspired: We love what we do One Global Team: We before me, always What you will do (job duties) Collaborate to maintain yearly Internal Audit Program. Execute Internal Audits Supporting External Audits (Customer, Notify Body, Inspections, etc.) Ensure the Company is prepared for internal, external and/or customer audits and inspections. Contributes to organizational change to create and sustain a work environment conducive to continuous improvement. Monitoring and maintain CAPA activities and Program. Support CAPA investigations as required. Supporting quality documentation, metrics, and reports by collecting, analyzing and summarizing information and trends,



including failed processes, stability studies, recalls, corrective actions and re-validations. Support to prepared Management Review presentation. Other duties as assigned.
Experiência y requisitos
What you will need Education: Bachelor's Degree in a science, technical discipline or Experience equivalent. Experience: At least 5- 10 years of QMS and leadership experience in medical devices. Languages: Bilingual - Strong verbal and written communications skills. Other Knowledge, Skills, Abilities or Certifications: Demonstrated experience working with diverse cultures. Strong organizational skills. Strong verbal and written communications skills. Demonstrated capability/experience raising issues and concerns and constructively challenging leadership to drive appropriate change and compliance. Effective communication Trainer skills Ability to establish and maintain effective interpersonal relationships at various levels of the organization. Experience with GMP, GDP, QMS, Audits, etc. as part of a Quality Culture.
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario** L / V
**Estudios** Carrera Cualificado
**Sexo** Indistinto
**Disponibilidad p. viajar** No

📌 Quality System Engineer (Tijuana)
🏢 Empresa reconocida
📍 Tijuana