Descripción y detalle de las actividades
Supports Quality System compliance by managing the Internal Audit process and CAPA system.
ESSENTIAL DUTIES AND RESPONSIBILITIES: -Implements and supports methodologies and systems that improve product quality and QS (Management Review, QSR Training, ISO13485).
-Assist organizational and group operations management in planning and implementing corrective action necessary to ensure continued compliance with division policy and procedures, Federal regulations under Title 21 CFR Part 820 and ISO 13485.
Makes sure the CAPA system is follow-up and it is effective.
-Plans, organize, implements and follow-up to make sure the Internal Audit Program is implemented and effective.
Performs routine internal quality system audits in compliance with division procedures.
Reports audit findings to both organizational management and senior management.
-Manager in the development, documentation, implementation, and maintenance of quality system procedures, instructions, and records.
-Works with the appropriate department management to initiate corrective action necessary to resolve quality related problems identified as a result of the routine analysis of product performance data -Reports on time results from Internal Audit Program and CAPA system (NMR, FI, Complaints) that would drive continuous improvement.
-Can participates in the preparation of objectives, training and development budgets.
-Participates and supports the Welch Allyn Quality Improvement Process as required by senior management.
Supports and helps implement the Welch Allyn Quality Principles by actively participating in error prevention and problem solving.
-May act as the CAPA coordinator.
-Member of the CAPA Review Board, acting as responsible for the oversight of the organization's CAPA system, and ensuring that it is established and maintained.
Experiência y requisitos
Education required: B.S.
Degree in Engineering Desirable experience: -Education or training in quality control techniques including quality system auditing, statistical process control, design of experiments, regression analysis, and statistical sampling methods.
-Three years of experience in manufacturing operation as quality or manufacturing engineer.
-Experience in medical device regulations and standards, including FDA medical device regulations covered under Title 21 CFR Part 820, European Medical Device Directive 93/42/EEC.
Bilingual: Oral and written communication in English required (basic).
Organización
Baxter Healthcare - Welch Allyn de Mexico, S. de R.L.
de C.V.
Giro
Maquiladora (Export.)
Actividad principal
Manufactura de instrumental médico de diagnóstico.
Número de empleados
990
**Área** Calidad
**Contrato** Permanente
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario** 07:00-17:00
**Estudios** Carrera Profesional
**Sexo** Indistinto