Descripción y detalle de las actividades
To develop, implement, communicate and maintain Quality Plan to bring the company’s quality systems and policies into compliance with quality systems requirements. To represent quality interests and concerns on project teams and support manufacturing operations. Manage Quality Systems, Quality Engineering, Environmental Control, Customer Complaints systems, CAPA, Internal Audit. Provide Leadership and business process improvements.
- Drives the Quality functions, assuring the development of the Quality System and the compliance to corporate Standards, FDA, QSR’s, ISO 13485 among other requirements.
- Provides direct supervision or technical guidance to QC inspectors.
- Plan and develop the quality control program for various projects often within the context of a project team.
- Perform validation studies on new products, processes or equipment as need it.
- Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.
- Conduct and generate detailed quality monthly reviews with engineering, manufacturing and management to assure and efficient Quality system, quality engineering studies to determine causes of Customer Complaints, Quality non-conformances, initiate changes in process, tooling, product design, etc., to correct them.
- Provide documented instructions for performance of QC inspections, including QC plans, inspection and test procedures, and quality standards
- Plan and coordinate quality activities which involve production, engineering to assure that products, molded parts and assemblies are developed and manufactured as per applicable requirements.




- Exercise control over the quality of conformance of the products generated in his area/Design and qualify inspection and test equipment.
- Implement corrective actions / projects to reduce Customer Complaints and Improve Internal product quality.
Experiência y requisitos
- Bachelor’s degree in technical sciences (or equivalent experience)
- A high level of competence in quality systems and technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability, etc.
- Experience in quality systems and technology, supervision, or management in medical devices industries.
- Good oral and written communication skills
- Ability to solve problem analysis tools and motivate people.
- Strong supervision skills & project management
- CQA, CQE preferred
- Experience on Quality System (FDA-CFR), GMP’s and ISO 13485
- Certified Internal Auditor
- Six Sigma Green Belt Certification
The scope of the work is across all phases of internal manufacturing, quality engineering, environmental, including suppliers and customers. The work has an impact on product quality and productivity costs as affected by internal and external costs of rework, scrap and product warranty. May include other activities not described and related to the function.
Beneficios
- Beneficios de acuerdo a la LFT
- Comedor
- comedor
- transporte
- servicios médicos en planta
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Jornada completa
**Horario**
- Tiempo completo
- Turno Matutino
- Lunes a viernes
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No

📌 Quality Manager (Tijuana)
🏢 Empresa reconocida
📍 Tijuana