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
• 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
• 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
• Print and apply labels onto pouches and blisters. Assist in label reconciliation as needed
• Operates pouch and blister sealing equipment and performs inspections per established work instructions
• Verify validated parameters and use of appropriate tooling
• Load and orient unit devices into unit packages and/or automated equipment
• Inspect 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
• Perform supplemental label application, blister loading, pouch and blister sealing and visual inspection
• Alert of any maintenance or repair issues of any equipment or tools
• Assist during changeovers and line setups
• Responsible for accessing and following packaging instructions and work instructions from PLM and Document management systems based on product structure requirements
• Responsible for managing and segregating scrap
• Ensure correct and complete assembly of device
• Responsible for DHR and ERP accuracy and completion
• Supports activities involving QC Hold and/or MRB related issues
• Promote a safe work environment including the use of PPE when required. Communicate 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
• 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
• 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 work independently when necessary

Specialized Courses and/or Training

• Proficiency with Microsoft Office products
• 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
• 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 work independently when necessary

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. Reasonable accommodations may be made 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.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Arthrex Benefits

• 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
• Anual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)