Production Supervisor

Essential Responsibilities

To oversee daily production activities in a medical device manufacturing environment, ensuring the efficient and safe production of high-quality medical devices. This role involves managing production staff, coordinating workflow, and ensuring compliance with industry standards, regulations, and company policies. The ideal candidate will have experience in medical device manufacturing, strong leadership skills, and the ability to work in a fast-paced, regulated environment.

• Operate, inspect, and troubleshoot production line machinery and/or assemblies.
• Supervise and lead the day-to-day operation of the production line, ensuring production schedules are met efficiently and on time.
• Ensure the production process follows established work instructions, regulatory requirements, and quality standards (FDA, ISO, etc.).
• Monitor production performance, track production yields, and address any deviations from standard procedures.
• Lead, train, and mentor a team of production workers to maintain a high level of performance, safety, and morale.
• Ensure all staff are trained on equipment, processes, safety protocols, and quality requirements.
• Conduct regular performance evaluations and provide feedback for improvement.
• Foster a culture of continuous improvement and ensure employee compliance with company policies and procedures.
• Ensure adherence to quality control standards by monitoring in-process inspections and final product reviews.
• Work closely with the Quality Assurance department to investigate non-conformances, identify root causes, and implement corrective actions.
• Maintain accurate records of production data, quality inspections, and any incidents that may impact product quality or safety.
• Enforce all safety procedures and ensure a safe working environment for the production team.
• Stay up to date with relevant regulations, including FDA, ISO 13485, and GMP (Good Manufacturing Practices), and ensure the team complies with these standards.
• Investigate and report any safety hazards or incidents to the appropriate departments and work on resolutions.
• Ensure timely availability of materials and components required for production.
• Coordinate with the materials and supply chain departments to monitor stock levels and prevent delays due to material shortages.
• Oversee proper documentation of material usage and assist in managing waste reduction.
• Identify opportunities for process improvements in efficiency, quality, and cost-effectiveness.
• Collaborate with engineering and operations teams to implement new manufacturing processes or technologies.
• Contribute to the development and implementation of lean manufacturing principles.
• Follow and enforce all established safety, health, quality GMPs and all applicable SOPs.
• Performs other duties as assigned based on business needs.

This position has direct supervisory responsibility.

This position operates in an office and manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The position also interacts with machinery on the manufacturing floor and numerous devices that are sold by the company.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and stoop; use hands to finger, handle or feel; and reach with hands and arms.

The employee frequently is required to lift and/or carry up to 20 pounds. For more information, please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.

This is a full-time position. Days and hours of work are Monday through Thursday, 5:00 a.m. to 4:00 p.m. Occasional evening and weekend work may be required as job duties demand.

This position requires no measurable travel.

• High School Diploma or equivalency

• 7+ years of Lead Operator experience in manufacturing or equivalent experience
• Working knowledge of Microsoft Office applications
• 6+ MRP/ERP experience

• 6+ years of clean room experience
• Medical device industry or regulated industry experience

• Experience following work instructions, process documentation, and procedures to ensure safe working conditions
• A…