What are the responsibilities and job description for the Production Manager position at GL Staffing Services?
Key Responsibilities
Production Leadership
Manage daily manufacturing operations to ensure production schedules, quality standards, and delivery commitments are achieved.
Lead and develop production supervisors, leads, and manufacturing personnel.
Monitor production metrics including productivity, efficiency, scrap, downtime, and labor utilization.
Coordinate with Quality, Engineering, Supply Chain, and Regulatory teams to ensure seamless operations.
Develop staffing plans and workforce strategies to support business growth.
Quality & Regulatory Compliance (Critical Function)
Serve as a champion for ISO 13485 compliance throughout all manufacturing activities.
Ensure all production processes adhere to ISO 13485 requirements, FDA regulations, and internal quality procedures.
Maintain strict control of manufacturing documentation, Device History Records (DHRs), batch records, and production logs.
Support internal audits, customer audits, and regulatory inspections.
Drive corrective and preventive actions (CAPA) related to manufacturing issues.
Ensure proper implementation and adherence to change controls, nonconformance management, and risk management processes.
Promote a culture where quality and compliance are integrated into every production activity.
Continuous Improvement
Implement Lean Manufacturing, Six Sigma, and continuous improvement initiatives.
Analyze production data to identify opportunities for process optimization and cost reduction.
Improve throughput, reduce waste, and enhance product quality.
Lead root cause investigations and implement sustainable corrective actions.
Safety & Employee Development
Foster a strong safety culture and ensure compliance with all workplace safety regulations.
Conduct performance evaluations, coaching, and employee development activities.
Train staff on quality requirements, SOPs, work instructions, and ISO 13485 standards.
Promote accountability, teamwork, and operational excellence throughout the production organization.
Qualifications
Required
Bachelor's degree in Engineering, Manufacturing, Operations Management, or related field.
5 years of manufacturing leadership experience in a medical device manufacturing environment.
Strong knowledge of ISO 13485 and FDA Quality System Regulations (21 CFR Part 820).
Experience managing production teams in a highly regulated environment.
Proven experience with CAPA, nonconformance investigations, and quality systems.
Strong understanding of manufacturing KPIs and operational metrics.
Excellent leadership, communication, and problem-solving skills.
Preferred
Lean Manufacturing or Six Sigma certification.
Experience with ERP/MRP systems.
Knowledge of risk management principles (ISO 14971).
Experience supporting FDA inspections and third-party audits.
Critical Success Factors
The successful Production Manager understands that ISO 13485 is not simply a certification requirement—it is the foundation of the medical device quality management system. This individual must ensure every manufacturing process, employee action, and production decision supports compliance, traceability, risk mitigation, and patient safety. Maintaining ISO 13485 compliance while achieving production objectives is a primary responsibility and key measure of success in this role.