Descripción y detalle de las actividades
Duties include execution of all quality-related activities. This includes but is not limited to Quality System; Quality Engineering functions; Inspection activities, Gage Calibration and Document Control. Responsible for all Documentation Control activities associated with Quality System requirements, including Device History Records (DHR), employee training records, validations, and other Quality Records. Responsible for ongoing adherence to external regulations as required by the Food and Drug Administration GMP, ISO 13485 and other applicable regulations. Reviews and approves documentation changes RESPONSIBILITIES: - Reviews Customer Complaints/Returns and provides reports as required. - Remake, Repair and Return reports - Maintains product quality by enforcing quality assurance policies and procedures and government requirements. - Coordinates and maintains compliance to ISO 13485 requirements. - Maintain MDSAP requirements. - Oversees company training programs relative to ISO certification and FDA requirements. Develops employee training requirements (in conjunction with Human Resources Department) to assure all regulatory requirements are met. Notifies departmental Supervisors of “out of compliance” conditions and works with departments to assure corrective actions are implemented and effective. - Executes Internal Audits.
- Responsible for establishing quality and reliability standards by studying product and customer requirements with management, production personnel, technicians and engineers. - Establishes in-process product inspection, rework standards and standards for the disposition of finished product. - Establishes product quality documentation system by developing and updating quality assurance procedures. - Generates product and process quality reports by collecting, analyzing and summarizing information and trends. - Directs the analysis of failures of internal systems and analyzes other process problems to develop corrective action through the continuous improvement process. - Assists other Demant sites with quality system
Experiência y requisitos
REQUIREMENTS: - Engineering degree - Work experience in the following fields: o ISO13485 o Internal audits o Product transfers o Process and equipment validation o Medical Devices as Quality Engineer o Problem solving techniques (5whys, 8Ds, Ishikawa, DMAIC) - Bilingual - Computer literate (Microsoft office & Minitab)
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Jornada completa
**Horario** Lunes a Jueves de 7am a 5:20pm y Viernes de 7am a 3pm
**Estudios** Titulo Profesional
**Inglés **Hablado: 85%, Escrito: 85%
**Sexo** Indistinto
**Disponibilidad p. viajar** Si