Production Supervisor – Medical Devices

1 day ago

Salem TN IN Mlops solutions Full time

Job Summary The Production Supervisor will be responsible for overseeing and coordinating day-to-day activities on the production floor ensuring that medical devices are manufactured efficiently on time and in full compliance with quality and regulatory standards This role leads a team of production technicians and operators enforcing strict adherence to Good Manufacturing Practices GMP ISO 13485 and FDA guidelines We are looking for a proactive and detail-driven supervisor to manage X-ray tube manufacturing processes with particular emphasis on oil filling vacuum processing and final assembly The ideal candidate will possess strong technical expertise in high-voltage component handling vacuum technologies and precision assembly within a cleanroom setting Close collaboration with engineering quality and maintenance teams is essential to maintain safe reliable and compliant operations Key Responsibilities Supervise and coordinate activities of production personnel to meet production goals Ensure compliance with company procedures quality systems ISO 13485 and FDA regulations 21 CFR Part 820 Monitor daily production schedules prioritize work orders and ensure timely completion Troubleshoot production issues and implement corrective and preventive actions CAPA where necessary Supervise day-to-day operations of the X-ray tube production line particularly oil filling vacuum sealing and final encapsulation stages Maintain accurate production records batch documentation and device history records DHR Train and evaluate production staff in standard operating procedures SOPs safety and GMP Collaborate with quality assurance engineering and supply chain teams for smooth production operations Participate in internal and external audits and support regulatory compliance efforts Identify areas for process improvement and assist in lean manufacturing initiatives o Ensure safe working conditions and compliance with health and safety policies Page 2 of 2 o Monitor and control oil filling operations including degassing thermal cycles and leak integrity tests o Train and mentor operators on handling vacuum pumps oil filling systems and safety protocols o Ensure in-process quality checks cleanliness and product traceability throughout the build Qualifications o Technical Diploma bachelor s degree in engineering Mechanical Electrical Industrial production or equivalent experience o 5 years of experience in a production supervisory role within the medical device pharmaceutical o Strong knowledge of GMP ISO 13485 and FDA 21 CFR Part 820 o Excellent leadership communication and organizational skills o Experience with ERP Odoo systems and production planning tools o Ability to work in a cleanroom environment if applicable Maintenance Oversight o Oversee preventive and corrective maintenance schedules for all production equipment o Work closely with the maintenance team to minimize unplanned downtime and ensure equipment reliability o Lead root cause analysis RCA for equipment failures and ensure timely corrective actions o Maintain accurate documentation of maintenance activities and equipment history Proprietary Notice Fo Job Type Full-time Pay 9 138 79 - 21 384 21 per month Benefits Provident Fund Schedule Day shift Work Location In person

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