Supervisor - Sterilization Operations

Arthrex; Ave Maria (FL); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Annual Bonus

Onsite Medical Clinics

Tuition Reimbursement Program

Job summary

Arthrex Manufacturing in Ave Maria, FL is seeking a Sterilization Supervisor to lead Sterilization Technicians and Material Handlers across shifts. You will ensure compliant, efficient sterilization processes and coordinate with Engineering, QA, and Maintenance.

The ideal candidate has a minimum of five years in production within a regulated environment and a bachelor’s degree. Two years of supervisory experience is preferred, with after-hours availability as needed.

Qualifications

• Bachelor’s degree required.
• Minimum 5 years of production experience in a regulated manufacturing environment.
• 2 years of supervisory experience preferred.
• Working knowledge of FDA regulations and ISO standards.
• Flexibility to support after-hours emergencies.

Responsibilities

• Ensure all product runs are scheduled and meet turnaround-time and quality requirements.
• Maintain proper segregation of processed vs. non-processed product.
• Coordinate downtime for preventive maintenance with Maintenance.
• Review and approve final processing data for certification.
• Approve system configuration logs daily; review temperature/humidity logs for compliance.
• Assist in calibration verification of instrumentation before use.
• Prepare month-end system performance reports.
• Provide guidance to Sterilization Technicians and Material Handlers.
• Collaborate with QA and Engineering on nonconformance management.
• Maintain documentation including counts, segregation, palletizing, handling requirements, damage reports.
• Review and approve weekly payroll hours.
• Assist in training operations employees.

Skills

Leadership

Communication

Regulatory compliance

Education

Bachelor's degree

Tools

MS Office

Process control software

Data acquisition software

Job description

Manufacturing - Ave Maria, FL, US, 34142

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

Essential Duties and 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

Education and Experience:

• Bachelor’s Degree required
• 5 years’ experience in a production environment required
• 2 years of supervisory experience preferred

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• 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

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
• Must be medically approved for respirator use.
• Must be able to tolerate exposure to high temperatures and high humidity (120°F and 60% RH for 20 minutes).
• While performing this job the employee is regularly required to talk or hear. The employee is frequently required to sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The position may require prolonged walking and standing, awkward postures, working at heights and in hot or cold conditions.
• The employee must occasionally lift and/or move up to 10 pounds.
• Must maintain medical qualification to wear prescribed respiratory protection and other personal protective equipment for extended times.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually moderate.

Drug Free Workplace Screening:

Employees in safety sensitive positions will be subject to drug screening prior to and during employment at Arthrex. The company’s drug testing procedure is part of the Arthrex Employee Reference Guide.

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Time Off
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.