Production Supervisor
Position Summary
The Production Supervisor is responsible for overseeing all cleanroom packaging operations during assigned shifts to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and company quality standards.
This role ensures that production schedules are met while maintaining strict adherence to regulatory, quality, and safety requirements. The Production Supervisor leads a team of packaging operators, manages resources, and drives continuous improvement initiatives.
The Production Supervisor and the team are responsible for all aspects of production and must be appropriately trained.
Main Responsibility: Clean Room ISO 7 (CR)
Support Responsibilities: Incoming Inspection (II), Final Packaging (CA)
Key Responsibilities
General
- Work as a team member and demonstrate strong leadership capabilities
- Ensure that all work (including first article inspection) is carried out in accordance with valid SOPs
- Ensure all employees are trained according to their roles and responsibilities
- Identify and address deviations in materials, processes, or equipment
- Coordinate training activities in collaboration with relevant departments
- Participate in production meetings
- Monitor daily staffing levels and report staffing needs or excess to the Production Manager
- Maintain an overview of current processes and production orders
- Ensure effective communication and delegate tasks within the team and across sub-areas
- Ensure optimal order processing with a continuous focus on performance and quality improvement
- Coordinate production planning with the Production Manager to ensure timely execution and optimal capacity utilization
Quality & Regulatory Compliance
- Ensure compliance with ISO 13485, cGMP, GDP, GDocP, internal SOPs, and company policies
- Identify, segregate, and document non-conforming materials; initiate NCs and escalate as required
- Perform and verify line clearance before and after production activities
- Maintain accurate documentation, including batch records, logbooks, and cleaning records
- Support internal and external audits (ISO, FDA, customer) and implement corrective actions
- Issue production and process approvals within defined authority
Operational Leadership
- Promote a right-first-time and accountability-driven culture
- Ensure adherence to GMP, SOPs, and company policies
- Coordinate technical and personnel-related aspects of the team, including regular meetings and shopfloor communication
- Supervise packaging operations to meet production schedules and quality standards
- Assign tasks, monitor performance, and provide coaching and feedback
- Ensure compliance with hygiene and gowning requirements
- Maintain cleanliness and organization of the cleanroom and surrounding areas
- Ensure workplace safety in accordance with OSHA regulations
- Oversee cleaning and sanitation activities in line with SOPs
- Collaborate with Production, Quality, and Engineering to resolve operational issues
Training & Development
Ensure all team members are trained and qualified for their assigned tasks
- Maintain up-to-date training records
- Support cross-training to enhance team flexibility
- Onboard new employees and ensure proper training and qualification
Inventory & Resource Management
- Monitor inventory levels of packaging materials and consumables
- Coordinate replenishment to ensure smooth operations
- Ensure accurate ERP transactions for material usage and waste tracking
Additional Responsibilities
- Support new product introductions and validation activities
- Participate in continuous improvement and operational excellence initiatives
- Perform additional tasks as assigned by management
Area of Responsibility
- Direct Reports: Employees assigned to the respective production sub-area
- Interfaces: Production Manager, Engineering, Quality, Sales / Internal Sales
Job Requirements
- Completed vocational training with additional qualification in leadership or management
- Minimum of 5 years of leadership experience in a production environment
- Minimum of 5 years of experience in a MedTech or pharmaceutical GMP-regulated environment
- Strong understanding of regulatory and quality requirements
- High level of reliability and accuracy, especially regarding hygiene and compliance standards
- Strong organizational and communication skills
- Basic IT proficiency (ERP systems preferred)
- Fluent English (spoken and written)
- Understanding of approval workflows and quality processes
Job Type: Full-time
Pay: $25.00 - $33.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Education:
Experience:
- leadership: 5 years (Required)
- ISO 13485: 5 years (Required)
Work Location: In person
