Manufacturing Associate

JobDiva, Inc.; Santa Clara (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

JobDiva, Inc. in Santa Clara, CA seeks an experienced Manufacturing Operations Specialist to manage daily production, lead cross-functional teams, and drive efficiency while ensuring GMP/GDP/ISO13485 compliance.

You will oversee schedule adherence, inventory accuracy, and production execution, supporting MES and SAP systems and Power BI reporting. 5+ years of operations leadership required.

Qualifications

• Requires 5+ years in manufacturing operations, production control, materials management, or related field.
• Experience leading cross-functional operations and presenting performance metrics to leadership.
• Knowledge of GMP, GDP, ISO 13485, and FDA-regulated environments.

Responsibilities

• Manage daily production activities and prioritize orders using MES and SAP/ERP systems.
• Coordinate with cross-functional teams to ensure production readiness and resolve issues.
• Lead production meetings and communicate production status, risks, and mitigation plans.
• Ensure schedule adherence, inventory accuracy, material availability, and production execution.
• Support MES, SAP, Power BI reporting, quality systems, and production support activities.
• Mentor team members and support production scale-up and capacity planning.
• Ensure compliance with ISO 13485, FDA QSR, GMP, GDP, and company standards.

Skills

Analytical thinking

Problem-solving

Communication

Mentoring

Continuous improvement

Cross-functional leadership

Education

Associate or Bachelor's degree in supply chain or manufacturing

Tools

MES

SAP/ERP

Power BI

Microsoft Excel

Job description

Roles & Responsibilities

• Manage daily production activities and prioritize production/rework orders using MES and SAP/ERP systems.
• Coordinate with cross-functional teams to ensure production readiness and resolve operational issues.
• Lead production meetings and communicate production status, risks, and mitigation plans.
• Ensure schedule adherence, inventory accuracy, material availability, and production execution.
• Support MES, SAP, Power BI reporting, quality systems, and production support activities.
• Manage inventory replenishment, kitting, staging, and Kanban processes.
• Analyze manufacturing data and drive process improvements, operational efficiency, and productivity gains.
• Standardization of processes, work instructions, reports, and training materials.
• Mentor team members and support production scale-up and capacity planning.
• Ensure compliance with ISO 13485, FDA QSR, GMP, GDP, and company standards.

Requirements

• High School diploma or equivalent with 5+ years of manufacturing operations, production control, materials management, supply chain, logistics, manufacturing systems, operations leadership, or related operational experience.
• Manufacturing operations and production control
• Inventory and material management
• MES and SAP/ERP systems
• Power BI and operational reporting
• Microsoft Excel and Office tools
• Experience leading operations, coordinating cross-functional teams, and presenting performance metrics to leadership.
• Knowledge of GMP, GDP, ISO 13485, and FDA-regulated environments.
• Strong analytical, problem-solving, communication, mentoring, and continuous improvement skills.
• Associate or bachelor's degree in supply chain, Manufacturing, Operations, Business, or related fields.
• Experience with Compliance Wire, Air table, SAP/ERP, MES, and Power BI.
• Background in production planning, inventory reconciliation, manufacturing systems, and process improvement initiatives.
• Lean Manufacturing, Six Sigma, or Operational Excellence Experience preferred.