Job
Description
Hiring Production Supervisor for a Medical Device Manufacturing company Job Title: Production Supervisor Medical Devices Location: Bengaluru Experience: 5 - 8 Years Department: Manufacturing / Operations Summary of the role: We are seeking a detail-oriented and proactive Production Supervisor to oversee the manufacturing operations of medical devices , with a specific focus on the X-ray tube production line . The role demands strong leadership, technical expertise in high-voltage components, vacuum processing, and precision assembly within cleanroom environments. The ideal candidate will ensure production efficiency, safety, and compliance with ISO 13485 , FDA 21 CFR Part 820 , and Good Manufacturing Practices (GMP) . Key Responsibilities Supervise and coordinate daily activities of production personnel to meet quality and productivity targets. Ensure strict adherence to quality systems ( ISO 13485 ) and regulatory requirements ( FDA 21 CFR Part 820 , GMP). Oversee end-to-end operations of the X-ray tube production line , including oil filling, vacuum sealing, and final encapsulation processes. Monitor production schedules, allocate resources effectively, and ensure timely completion of work orders. Identify, troubleshoot, and resolve production issues, implementing appropriate Corrective and Preventive Actions(CAPA) . Maintain complete and accurate production records, including batch documentation and Device History Records (DHR) . Train, coach, and evaluate production staff on SOPs, safety protocols, and regulatory compliance. Collaborate with cross-functional teams including Quality, Engineering, and Supply Chain to ensure smooth and compliant operations. Support internal and external audits and drive regulatory compliance initiatives. Continuously assess and improve production processes by contributing to Lean manufacturing , 5S , and Kaizen activities. Required Qualifications and Skills Bachelors Degree or Diploma in Engineering(Mechanical, Electrical, Biomedical, or related field). 5+ years of relevant experience in medical device manufacturing , preferably involving high-voltage and vacuum component production. Strong knowledge of ISO 13485 , GMP , FDA 21 CFR Part 820 compliance. Hands-on experience with cleanroom protocols, SOP documentation, and regulated manufacturing environments. Proficiency in handling CAPA, DHR documentation, and batch production reporting. Leadership experience in managing shop-floor teams and cross-functional collaboration. Familiarity with production planning systems and ERP tools is a plus. Key Competencies Leadership & Team Coordination Regulatory Compliance & Documentation Process Troubleshooting & Root Cause Analysis Continuous Improvement Mindset Strong Communication & Interpersonal Skills Attention to Detail and Quality Orientation For further information or any clarification, please reach us on rajbm@mlopssol.com
