Business Unit Quality Manager

hace 3 días

Tijuana, México Emprego MX A tiempo completo

Descripción y detalle de las actividades

The B.U. Quality Manager is responsible for the overall direction, coordination and evaluation of the quality system and ISO 13485 in both of our plants (Tijuana and North Carolina). He/she will also be responsible of conducting gap analysis of our QMS and, together with the local quality managers and plant managers, implement actions to close those gaps and make the overall QMS better for our customers. Main activities: - Internal companywide audit team member & Medical BU representative. - Work with Product Development to develop functional product specifications prior to new product commercialization by conducting capability studies on both new and existing products. - Maintain customer specifications and changes. - Interact with manufacturing managers, engineering, and quality managers to ensure quality procedures are clearly understood and followed. - Support continuous improvement efforts and implementation of Printpack Performance System. - Interact with external raw material suppliers. - Interact with customers and visit as necessary to build relationships, respond to complaints and support audit activity. - Aligns quality cultural expectations with local plant managers, engineering teams, and Printpack Performance System program fundamentals. - Leads department wide talent and succession planning activities to support business growth. - Responsible for all business unit shipped product on both our sites. - Represents business unit on corporate functional projects and development programs.

Experiência y requisitos
- Fluent in English language. - Strong knowledge of ISO 13485. - Bachelor’s degree in lean, quality, or engineering disciplines. - At least 7 years of quality experience in QA management and QMS system management. - Willingness to travel up to 50% - Strong statistical quality control methods. - CAPA process management, improvement and execution. - Leading, managing and supporting customer and ISO 13485 facility audits. - Supplier quality development practices, supplier audits, CAPA remediation activities, etc. - Process/product qualification and validation practices, change control process management. - Overall quality methodology and cultural transformation to a data driven quality mindset. - Lean tools.

Organización

Printpack Tijuana, S.A. de C.V.

Giro

Manufacturera

Actividad principal

Somos empresa lider en la Manufactura de empaques para productos medicos.

Número de empleados

130

**Área** Calidad

**Contrato** Permanente

**Turno** Diurno

**Jornada** Tiempo Completo

**Estudios** Carrera Profesional

**Inglés **Hablado: 90%, Escrito: 90%

**Sexo** Indistinto

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