Production Supervisor

About the role

The Production Supervisor (PS) leads manufacturing shifts that make single-use medical supplies safely, on schedule and in full compliance with the Quality Management System. The role owns daily shift output, cleanroom discipline, Good Documentation Practices and the development of the production team. It is the first line of accountability for product quality, safety and regulatory readiness on the floor.

Responsibilities

• Accountable for achieving Production targets
• Plan and run the shift production schedule to meet daily, weekly and monthly output targets.
• Assign operators to lines and workstations (film welding/RF and impulse sealing, tubing cutting and assembly, connector and fitting assembly, bag forming, leak and integrity testing, labeling, packaging).
• Monitor line performance, throughput, scrap and downtime in real time; act on deviations from plan.
• Coordinate with Planning, Materials, Warehouse and Maintenance on material availability, line changeovers and equipment readiness.
• Verify line clearance before every lot and product changeover to prevent mix-ups.
• Hand off shift status, open issues and priorities to the next shift in writing.
• Enforce compliance with ISO 13485:2016, FDA 21 CFR Part 820 (Quality Management System Regulation), EU MDR 2017/745 where applicable, and site SOPs and work instructions.
• Ensure every lot is built to the current Device Master Record / Medical Device File and that Device History Records (batch records) are complete, accurate and timely.
• Apply Good Documentation Practices (ALCOA+) on the floor and correct documentation errors at the source.
• Initiate and support nonconformance reports (NCRs), deviations, investigations and CAPAs; lead root-cause work for production-related issues.
• Participate in internal, customer, notified body and FDA audits and inspections; present shift practices and records.
• Support process validation (IQ/OQ/PQ) and change control by releasing operators and equipment for runs and executing protocol steps as assigned.
• Control nonconforming material through quarantine, labeling and MRB disposition.
• Enforce gowning qualification, cleanroom behavior and material transfer procedures.
• Ensure scheduled cleaning and sanit