Job Description

General Objective:

Responsible for supervising and coordinating the activities of employees engaging in terminal sterilization. Ensures the proper systems and resources are in place to meet processing schedules on time and that operation is in complaince with SOP’s, cGMP’s, 21 CFR Part 820, IS011135, IS013485 and safety procedures.

Responsabilities:

• Implements operational strategies and plans by collecting, analyzing and preparing reports for review by appropriate company management.

• Ensures customer product is properly received through monitoring movement and storage of unprocessed and processed product in a manner to permit accurate tracking and minimal product damage.

• Ensures customer product is processed according to specified procedure by maintaining machines and equipment for proper operation and minimized downtime and deviations; perform minor repairs when needed until maintenance is required for more complex repairs.

• Ensures customer product is properly shipped by monitoring product movement from storage through shipment in a manner that minimizes product damage and accuracy of shipping documentation.

• Leads assigned staff through coaching, counseling, motivating and disciplining as needed; planning, monitoring and appraising job results; directing and maintaining activities designed to achieve and maintain high employee morale: fostering intra- and inter-department cooperation.

• Maintains mechanical and technical skills, knowledge and abilities by attending training and participating in training operators and material handlers to conduct minor, basic repairs to equipment, machinery, etc.

• Trains and maintains ability to function as Operator in backup situations.

• Maintains a safe, clean and secure working environment by enforcing procedures, rules and regulations: monitoring all safety and security systems and procedures on a regular basis, advising management of unsafe work practices or conditions. Identifyes and anticipates safety training needs.

• Ensures compliance with Corporate QSRC and GMP procedures by monitoring established programs; monitoring production and scheduling activities on a daily basis.

• Monitors and controls sterilization processes from workstation in Control Room.

• Ensures continuity of production from shift to shift by communicating person-to-person daily with other shift supervisors including discussion of processing, maintenance or quality problems occurring during the preceding shift

• Supports appropriate processing documentation by assisting with validation efforts when needed.

• Provides protection to employees by promoting personal protection and issuing monitoring devices in hazardous areas as required by safety rules and laws.

Experiencia/ conocimientos técnicos

• Medical Device manufacturing experience

• Experience as a production supervisor and process engineer with good communication skills

• Mechanical, mecatronic, chemical & background 3-5 Years

Competencias /softskills

• Effective communication

• Proactive

• Teamwork oriented

• Schedule Availability

• Sense of Urgency

• Safety oriented.

• Able to work under pressure

Formación académica

• Bachelor Degree

• Bachelors of Science degree

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.