Sr. Quality Systems Engineer

hace 2 semanas

Mexicali, México Medline A tiempo completo

Descripción y detalle de las actividades

The Sr. Quality Systems Engineer is the responsible in the development, implementation and follow up of the QMS (MDSAP, ISO13485 & FDA 21CFR Part 820) for MXC ensuring compliance to the applicable standards and regulations for the medical devices. Develop the internal audit program in MXC. Acts as Auditor Leader during Corporate Internal Audits, FDA, BSI and Customer Audits across all areas of the business. Responsible for managing the Document Control activities through the EtQ Reliance system to ensure its effectiveness. Coordinate and follow up the CAPA system. Coordinate customer complaints investigations and communicate them to team members. Lead quality projects improvements based on quality data trends. This position requires strong knowledge in Quality Systems Standards and Regulations (MDSAP, ISO13485, MDSAP & FDA 21 CFR Part 820) in the medical device manufacturing environment. - Assure compliance of all applicable Quality System Standards and Regulations (MDSAP, ISO13485, MDSAP & FDA 21CFR Part 820). - Perform gap assessment to the QMS. - Implement and maintain Quality Management System and related documentation and procedures for MXC as required. - Support the goals and objectives of the organization within the Mexicali facility. - Revise QA complaints in SAP module. (desirable) - Interface with complaint corporate department the review of customer complaints - Lead and support quality process improvement projects. - Maintain the Quality Scorecard updated as required. - Provide training to new employees on the Quality System and EtQ Reliance. - Support in the planning and execution of the Quality Week activities. - Participate in the different programs of the organization as required.

Experiência y requisitos

Bachelor's Degree: Engineering, or an equivalent 3-5 years of experience in Medical Device Quality Systems English fluid 85-90%) Experience in Internal/External Audits Knowledge of ISO13485, MDSAP & FDA 21CFR820 Problem-Solving Skills Certified as an Internal Auditor (Preferably) Office Windows: Word, Excel, Power Point, etc. ETQ Reliance, AS400 ERP Systems (AS400, SAP). Desirable Communication Teamwork Proactive Results Oriented Sense of urgency Organized Responsible

**Número de vacantes** 1

**Área** Calidad

**Contrato** Permanente

**Modalidad** Presencial

**Turno** Diurno

**Jornada** Tiempo Completo

**Horario** Lunes a viernes de 8:00 a.m. a 5:00 p.m.

**Estudios** Carrera Profesional

**Sexo** Indistinto

**Disponibilidad p. viajar** No

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