Operations Specialist- (Packaging) - Ave Maria, FL.

About the role

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing, located in Ave Maria, FL, is actively seeking an Operations Specialist to produce Quality Medical Instruments in accordance with Arthrex Manufacturing Inc. procedures and packaging processes in a safe and effective manner to meet and exceed the customer's needs.

Responsibilities

• Performs and documents inspections on parts using engineering prints, inspection procedures or work instructions
• Supports production personnel in the assembly, inspection, and packaging of products
• Records data, applying statistical quality control procedures
• May perform, as needed, nondestructive tests on materials, parts, or products to measure performance, life, or material characteristics
• Prints and applies labels onto pouches and blisters
• Assists in label reconciliation as needed
• Operates pouch and blister sealing equipment and performs inspections per established work instructions
• Verifies validated parameters and use of appropriate tooling
• Loads and orients unit devices into unit packages and/or automated equipment
• Inspects unit assembled and sealed for potential defects
• Assists Production Coordinator/Sr. Production Coordinator with setting up lines
• Performs daily cleaning, monthly terminal cleaning and semi-annual terminal cleaning activities in the clean room
• Manages and segregates scrap
• Ensures correct and complete assembly of device
• Supports activities involving QC Hold and/or MRB related issues
• 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
• Adhere to all Quality System Requirements

Requirements

• High School Diploma or equivalent required
• 1 year of manufacturing, or, a combination of 1 year of manufacturing and quality control experience required
• Successful completion of the Competency Training within 3 months of hire

Knowledge and Skill Requirements

• Proficiency with Microsoft Office products is desired
• A thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements
• Ability to correctly perform tasks by reading, understanding and following work instructions provided
• Knowledge and ability to interpret/comprehend blueprints, written specifications, technical documents and protocols, rework addendums, data forms, and packaging and work instructions
• Possess thorough and accurate documentation skills according to GDP
• Perform tests and evaluations on materials, products, and processes to measure performance, life, or material characteristics
• Ability to assess, investigate, and assist in resolving departmental matters
• Ability to communicate both proactively and effectively all issues and concerns to the team and management in written and verbal formats
• Ability to write and record data and information as required by procedures

Physical Demands

• Reasonably accommodated to enable individuals with disabilities to perform the essential functions
• While performing the duties of this job, the employee is regularly required to talk or hear
• The employee is frequently required to sit and/or stand; use hands and fingers, to handle, or feel; and reach with hands and arms
• The employee must occasionally lift and/or move up to 30 pounds
• Visual acuity necessary to do the job safely and effectively
• Specific vision abilities required by this job include close vision

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job
• Requires frequently working in clean room and controlled environment utilizing specified cleaning agents