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

Arthrex; Ave Maria (FL); On-site; USD 32,000 - 42,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Flexible Spending Account (FSA)

Annual Bonus

Paid Time Off

Tuition Reimbursement

Job summary

Arthrex Manufacturing in Ave Maria, FL is seeking an Operations Specialist to support assembly, inspection, and packaging of quality medical instruments in line with Arthrex procedures.

This role operates on third shift (Sunday–Thursday, 10:00 pm–6:30 am) and emphasizes GDP compliance, cleanroom protocols, and meticulous data documentation while assisting with line set-ups and continuous improvement initiatives.

Qualifications

• High school diploma or equivalent required.
• 1 year of manufacturing or 1 year manufacturing and quality control experience required.
• Successful completion of the Competency Training within 3 months of hire.

Responsibilities

• Perform 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 or clean-room assemblies.
• Record data, applying statistical quality control procedures.
• Conduct nondestructive tests on materials or products as needed.
• Print and apply labels onto pouches and blisters and assist with label reconciliation.

Skills

Packaging processes

Product assembly

Visual inspection

Labeling requirements

Blueprints interpretation

Documentation skills

GDP knowledge

Education

High School Diploma or equivalent

1 year manufacturing or 1 year manufacturing and quality control experience

Competency Training within 3 months

Tools

Microsoft Office

Job description

Operations Specialist – Packaging (Ave Maria, FL)

Third Shift – Sunday‑Thursday, 10:00 pm – 6:30 am

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. The role supports production personnel in assembly, inspection, and packaging, ensuring that production plan goals are met and exceed customer needs. Continuous improvement is encouraged to develop robust procedures and cost‑effective quality products.

Essential Duties and Responsibilities

• Perform and document 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 clean‑room specific device assembly as assigned
• Record data, applying statistical quality control procedures
• Conduct nondestructive tests on materials, parts or products to measure performance, life or material characteristics as needed
• Print and apply labels onto pouches and blisters; assist with label reconciliation as needed
• Operate pouch and blister sealing equipment and perform 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
• Assist the Production Coordinator with setting up lines
• Perform daily cleaning, monthly terminal cleaning and semi‑annual terminal cleaning 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 equipment or tools
• Assist during changeovers and line setups
• Follow packaging instructions and work instructions from PLM and document management systems based on product structure requirements
• Manage and segregate scrap
• Ensure correct and complete assembly of device
• Maintain DHR and ERP accuracy and completion
• Support QC Hold and/or MRB related activities
• Promote a safe work environment by using PPE when required and communicating issues that could result in process delays or safety hazards
• Adhere to all Quality System Requirements

Education and Experience

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

Knowledge and Skill Requirements / Specialized Courses and/or Training

• Proficiency with Microsoft Office products desired
• Thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements
• Ability to read, understand, and follow work instructions provided
• Knowledge and ability to interpret 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
• Assess, investigate, and assist in resolving departmental matters
• Communicate proactively and effectively all issues and concerns to the team and management in written and verbal formats
• Work independently when necessary

Measuring and test equipment, PC and spreadsheets. Comprehension is required to perform the following operations/tasks: operation of the label dispenser machine, label printers, heat sealers, crimping machine, weighing scales, peel testing equipment, automated /semi‑automated glue dispensing equipment, arbor press, tygon tube cutter, wire cutter, small hand tools, fixtures, and any advanced clean‑room specific equipment as assigned.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and handle several abstract and concrete variables.

Mathematical Skills

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

Language and Communication Skills

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Verbal communication of ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

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, 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.

Vision Requirements

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 a 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
• Annual 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)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.