Sr. Quality Engineer
hace 1 mes
Descripción y detalle de las actividades
Job Purpose: Support and assist the Sr Quality Assurance Manager and Quality Engineers in maintaining a highly compliant quality management system with a strong focus on customer complaints and coordinating and executing quality inspections and process audits. Responsible for Quality oversight and support for QC and Operation teams. Duties include performing product, process, and change control risk mitigation actions, utilizing Control Plans, pFMEAs, and Flow Diagrams. Risk Assessment Audits, 5S Audits, and ISO-based Internal Audits Work Instructions, Process Mapping, and Checklists. Create and implement new ISO 9001 and ISO 13485 procedures and work instructions. Provide quality engineering support to all departments. Performs statistical analysis and writes technical reports. Be an expert in quality statistics, including establishing sample sizes, statistical analyses, and acceptance criteria. Responsible for approving change control deliverables, assisting complaints investigation and change control closure in a timely manner, supporting review of regulatory compliance of product manufacturing, and supporting continuous improvement efforts for medical device development-related processes. Key tasks: - Provide quality engineering support to all departments. - Performs statistical analysis and write technical reports. - Conducts and documents product quality inspections and Internal Audits. - Work with in-house systems and other databases - Assist in preparation and updating documents including procedures work instruction SOPs for quality and environmental management system. - Run queries within databases to generate quality reports - Performs process audits in accordance with work instructions - Reviews customer complaints at the moment of initiation and closure for proper coding in SFDC. - Support investigation of customer complaints.
Experiência y requisitos
- Associate Degree in Engineering Technology (or equivalent) or 2 to 4 years of equivalent experience. -2+ years of experience in quality assurance/control experience within a medical device manufacturing site is required. -Strong interpersonal & communication skills. -Problem solving attitude -Strong analytical skills; technical & conceptual aptitude -Ability to train & lead team members -Teamwork -Responsibility -Demonstrate Integrity through work ethic, personal accountability, professional image, and ethical behavior. - Must be able to read and follow written and verbal instructions in English.
Organización
Sonova
Correo de contacto
Giro
Manufacturera
Actividad principal
Proveedor de soluciones de cuidado auditivo - Dispositivos Médicos
Número de empleados
800
Aviso de privacidad
- /mexico/es/politica-de-privacidad-de-la-web-y-cookies**Área** Calidad
**Contrato** Permanente
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Titulo Profesional
**Inglés **Hablado: 80%, Escrito: 80%
**Sexo** Indistinto
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