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Arthrex · 1 day ago

Senior Production Coordinator (Packaging)-3rd Shift- Ave Maria, FL.

Ave Maria, FL

Full-time

Onsite

Mid, Senior Level

3+ years exp

Arthrex Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Senior Production Coordinator will produce Quality Medical Instruments in accordance with Arthrex Manufacturing Inc. procedures and packaging processes, ensuring production goals are met and fostering continuous improvement in processes.

Health CareMedical Device

Comp. & Benefits

Responsibilities

Perform daily, monthly and semi-annual terminal cleaning activities in the clean room

Responsible for accessing and following packaging instructions and work instructions from PLM and Document management systems based on product structure requirements

Perform manual and fixture assisted device assembly and packaging on medical device components, kits, convenience packs and/or any clean room specific device assembly as assigned

Responsible for DHR and ERP accuracy and completion

Apply labels onto pouches and blisters including label reconciliation

Perform supplemental label application, blister loading, pouch and blister sealing and visual inspection

Operate clean room specific equipment, automated robotic assembly equipment as needed

Alert of any maintenance or repair issues of any equipment or tools

Perform changeovers and line setups

Perform area clearance and maintain line separation while running work orders

Responsible for managing and segregating scrap

Ensure correct and complete assembly of device

Performs AQL inspection in accordance with stated inspection criteria

Manages activities involving QC Hold and/or MRB related issues

Assist in product and packaging validation tests when necessary

Adhere to all Quality System Requirements

Promotes a safe work environment including the use of PPE when required. Communicates issues to management that could result in process delays and/or safety issues

Train all employees on device assembly and packaging techniques

Qualification

Packaging processesDevice assemblyLean ManufacturingMS OfficeSAPAgile PLMVisual inspectionTeam coordinationCommunication skillsProblem solvingDocumentation skills

Required

High School Diploma or equivalent required

2 year of manufacturing experience related to technical and mechanical aspect of manufacturing including operation of packaging equipment and 1 year experience in a previous position of leadership required

Successful completion of the Competency Training within 3 months of hire

Proficiency on MS Office required

A thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements

Perform tasks by reading, understanding and following work instructions/documents provided

Understanding of Work Instructions, Routers, BOM's, and DHR's required

Ability to interpret/comprehend blueprints, written specifications, technical documents and protocols, rework addendums, data forms, and packaging and work instructions

Advanced knowledge of raw materials, inventory traceability and investigation, production processes, barcode scanning and labeling controls, inspection methods and equipment, and other techniques for the effective manufacturing and distribution of goods

Ability to generate appropriate product identification labels for Packaging requirements

Possess thorough and accurate documentation skills according to GDP

Knowledge of administrative procedures and computer systems such as word processing, Documentum, SAP, Agile PLM and Microsoft Outlook

Perform tests and evaluations on materials, products, and processes to measure performance, life, or material characteristics

Ability to perform machine setup, verifies validated parameters, determination/ installation and use of appropriate tooling

Requires business language reading and comprehension, solving simple math equations and the ability to perform tasks through verbal communication

Ability to communicate both proactively and effectively all issues and concerns to management, other coordinators and operators in written and verbal formats

Work Order problem solving and DHR documentation and reconciliation

Ability to monitor lines for process improvement

Ability to assess, investigate, and bring resolution to departmental matters

Ability to efficiently coordinate all resources to ensure production schedules are met as well as quality and accuracy of work performed meets GMPs

Assists other Coordinators ensuring proper utilization of manpower for continuous flow on the production line

Provides back up supervision for Packaging Clean Room when supervision is not present

Ability to train operators and other trainers on competency tasks

Regularly contributes to the development of new concepts, techniques, and standards

Considered expert in field within the organization

Develops solutions to complex problems, which require the regular use of ingenuity and innovation

Ensures solutions are consistent with organization objectives

Work is performed with minimal direction

Exercises considerable latitude in determining objectives and approaches to assignment

May be tasked with coordinating efforts of a team through a Supervisor's guidance

Ability to define problems, collects data, establish facts, and draw valid conclusions

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above

Ability to verbally communicate ideas and issues effectively to other team members and management

Ability to write and record data and information as required by procedures

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

Visual acuity necessary to do the job safely and effectively

Specific vision abilities required by this job include close vision

Requires frequently working in clean room and controlled environment utilizing specified cleaning agents