Supervisor - Sterilization Operations

Arthrex•Ave Maria, FL

17h•Onsite

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing is actively seeking a Sterilization Supervisor who will be responsible for the safe, efficient, and compliant operation of sterilization processes within a regulated medical device manufacturing environment. This role oversees production scheduling, maximizes equipment utilization, and ensures products are processed to meet quality and operational requirements across multiple shifts. The Sterilization Supervisor provides direct leadership to Sterilization Technicians and Material Handlers while partnering with Engineering, Maintenance, Quality, and Operations teams. The ideal candidate is an organized, business-minded people leader who communicates effectively, provides clear direction, and fosters a collaborative team environment. This position requires a minimum of five years of production experience, including experience in a regulated manufacturing environment, and a bachelor’s degree. Two years of leadership experience is preferred. The role requires flexibility and responsiveness to operational issues, including after-hours support when needed. A working knowledge of FDA regulations and ISO standards is essential. The focus of this role is to sustain established processes, maintain compliance, and ensure safety, quality, and operational excellence while meeting or exceeding company and regulatory standards. This position is based at our manufacturing facility in Ave Maria, FL. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™

Requirements

Bachelor’s Degree required
5 years’ experience in a production environment required
Ability to work at a desk, in an office area, or in a light manufacturing area including clean room.
Extensive computer skills including Microsoft Office products and data entry, data acquisition and process operation software.
Knowledge of and ability to implement ISO and FDA QSR requirements.
Extensive experience with process safety including hazard communication, respiratory safety, electrical safety and chemical handling safety procedures.
Must be willing to work established shifts
Must be willing to be available 24/7 in the event of an emergency

Nice To Haves

2 years of supervisory experience preferred

Responsibilities

Ensures that all product runs are scheduled and run in a manner consistent with the AMI turnaround-time and quality requirements
Maintains proper segregation of processed and non-processed product at all times
Coordinates downtime for preventative maintenance with the Maintenance Department
Reviews and approves all final processing data prior to certification to ensure that cycle times and loading patterns are in compliance with specifications
Approves system configuration logs on a daily basis; reviews temperature and humidity logs for accuracy and compliance
Aids in verification that all instrumentation has been calibrated before use
Prepares month end reports that detail system performance
Provides direction and support for the Sterilization Technicians and Material Handlers, routine feedback on performance issues and information pertaining to the operation
Collaborates with Quality Assurance and Engineering on nonconformance management and resolution
Maintains proper documentation and adherence to requirements including: Physical counts, Product segregation, Palletizing and loading patterns, Special handling requirements, Damage reports, Company procedures
Reviews and approves weekly payroll hours
Responsible for assisting in the training of all operations employees