Associate Production Manager

Key Responsibilities:

• Supervise and manage daily production operations for nephrology-focused medical devices, ensuring alignment with the production schedule and quality requirements.
• Lead a team of production supervisors, operators, and technicians; assign responsibilities, monitor performance, and provide necessary training.
• Ensure all manufacturing processes comply with ISO 13485, GMP, FDA 21 CFR Part 820, EU MDR, and local regulatory guidelines.
• Collaborate with Quality Assurance, R&D, Maintenance, and Supply Chain teams to meet production goals and resolve issues.
• Monitor key performance indicators including productivity, yield, scrap rate, downtime, and on-time delivery.
• Drive continuous improvement initiatives such as Lean Manufacturing, 5S, Six Sigma, and Kaizen to optimize efficiency and reduce waste.
• Maintain accurate production documentation, batch manufacturing records, and device history records (DHR).
• Participate in internal and external audits; ensure CAPA implementation for production-related observations.
• Assist in process validations equipment qualification, and new product industrialization.
• Monitor inventory levels of raw materials, WIP, and finished goods in coordination with the inventory and planning team.
• Ensure safe working conditions and compliance with health, safety, and environmental standards.

Required Qualifications & Experience:

• Bachelor’s degree in Mechanical, Electrical, Biomedical, or Industrial Engineering or equivalent technical field.
• 6–10 years of experience in medical device manufacturing, with at least 2 years in a supervisory or managerial role.
• Experience with nephrology devices is highly preferred.
• In-depth understanding of GMP, ISO 13485, and other medical device manufacturing standards.
• Familiarity with ERP systems (e.g., SAP), MES, and documentation tools.

Skills & Competencies:

• Strong leadership and team management skills.
• Ability to troubleshoot technical issues on the shop floor.
• Excellent planning, organizational, and decision-making abilities.
• Good knowledge of lean tools and process optimization.
• Effective communication and interpersonal skills.