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Skills
Communication Skillsunmatched
Computer Softwareunmatched
Continuous Improvementunmatched
Corporate Policiesunmatched
Cross-Functionalunmatched
Customer Relationsunmatched
Data Collectionunmatched
Documentationunmatched
Environmental Management Systemsunmatched
Establish Prioritiesunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
Hand Toolsunmatched
Healthcare Qualityunmatched
Loading/Unloadingunmatched
Manufacturingunmatched
Manufacturing Managementunmatched
Material Movingunmatched
Medical Equipmentunmatched
Operations Processesunmatched
Order Picking/Packingunmatched
Pallet Jackunmatched
Performance Metricsunmatched
Problem Solving Skillsunmatched
Product Flowunmatched
Profit & Lossunmatched
Quality Assuranceunmatched
Quality Managementunmatched
Quality Metricsunmatched
Record Keepingunmatched
Regulatory Requirementsunmatched
SAPunmatched
Safety/Work Safetyunmatched
Sterilizationunmatched
Team Playerunmatched
Traceabilityunmatched
Warehousingunmatched
Description
Job Title: Operator I - 2nd Shift Location: 26531 Ynez Road Temecula, CA 92591 Job Type: 12 Months of Contract + possible extension Shift: 1:00 PM to 9:30 PM Monday Friday
Job Description
This position is responsible for the production of high quality medical devices within a manufacturing cell.
Loads, unloads, and moves materials using pallet jacks, carts or other devices as required within warehouse and between campus buildings.
Packs and labels product for processing. Generate labels and applies to materials with emphasis on part number, lot/batch number and quantity.
Utilize hand tools to open containers.
Maintain a neat and safe work environment.
Assist in the coordination and flow of product through sterilization process .
Work in a cross functional team environment.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned.
Records appropriate sterilization information on LHRs (Lot History Records) and Sterilization Load Documents to provide traceability.
Performs SAP transactions to clearly identify status of product. operate electronic emissions beam ( E-Beam) Builds pallet configurations according to appropriate documentation for sterilization processes.
Schedule s sterilization loads for internal sterilization and external contract sterilizers.
Supports sterilization validation activities routine assignments according to specified and/or standardized procedures.
Work is closely and continually reviewed.
Ensure that relevant job documentation for cell operations and functions is accurate and up to date.
Be able to clearly communicate ideas, problems and solutions to all levels of manufacturing management in both written and oral form.
Maintain a positive attitude when interacting with internal customers and external customers such as tours.
Follow safety guidelines and utilize appropriate safety devices when performing all operations.
Participate in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics.
Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products.
Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics that continuously seek to improve the quality of operations.
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Ability to read, comprehend, and follow written procedures; understand and follow verbal instructions - Understanding of and ability to utilize electronic data collection systems and computer software packages. Ability to prioritize work by determining the sequencing and timing of different jobs based on precedence and importance. High school degree or equivalent required.