Regulated Manufacturing Supervisor - Lean & Quality

North American Production Sharing de México, S.A. de C.V.; Tijuana; Presencial; MXN 240.000 - 360.000; Jornada completa

Descripción de la vacante

North American Production Sharing de México, S.A. de C.V. is seeking a Production Supervisor with experience in regulated manufacturing to lead daily operations, ensure schedules and drive quality, safety, and performance.

Required are 3–5 years in a supervisory role within Medical Device/ Biotech/Pharma, knowledge of ISO 9001/13485, and strong leadership with advanced English for cross-functional meetings and reports.

Formación

• Experience in regulated manufacturing environments (Medical Device/ Biotechnology/Pharmaceutical).
• Knowledge of ISO 9001 and ISO 13485 Quality Management Systems.
• Experience managing production personnel, equipment and resources.
• Proficient with MRP/ERP systems (SAP/Oracle).
• Experience monitoring and reporting KPIs and production metrics.
• Knowledge of CAPA, RCA and Non-Conformance Investigations.
• Strong leadership, communication, and organizational skills.
• Advanced English required for meetings, reports and cross-functional interactions.

Responsabilidades

• Lead daily manufacturing operations to meet schedule safely and efficiently.
• Coordinate personnel, materials and resources to meet quality and productivity goals.
• Ensure compliance with internal procedures and regulatory requirements.
• Lead investigations related to deviations and CAPA implementations.
• Monitor and report production performance through KPIs and metrics.
• Oversee training, performance management and competency certification.
• Support workforce planning and development activities.
• Promote safety, quality and continuous improvement culture.
• Drive Lean, 5S and Six Sigma initiatives to reduce waste and improve processes.
• Collaborate with cross-functional teams to meet customer requirements and production goals.

Conocimientos

Leadership

English (Advanced)

ISO 9001/13485

MRP/ERP (SAP/Oracle)

KPIs & production metrics

CAPA / Root Cause Analysis

Training & development

Lean Manufacturing

5S / Six Sigma

Cross-functional collaboration

Problem solving

Quality & compliance

Cleanroom environment

Educación

None

Herramientas

SAP

Oracle

ERP systems

Descripción del empleo

North American Production Sharing de México, S.A. de C.V. is seeking a Production Supervisor with experience in regulated manufacturing to lead daily operations, ensure schedules and drive quality, safety, and performance.

Required are 3–5 years in a supervisory role within Medical Device/ Biotech/Pharma, knowledge of ISO 9001/13485, and strong leadership with advanced English for cross-functional meetings and reports.