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

National Society for Black Engineers; Ave Maria (FL); On-site; USD 48,000 - 68,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Matching

Annual Bonus

Tuition Reimbursement

Job summary

Arthrex Manufacturing in Ave Maria, FL, seeks an Operations Specialist to produce quality medical instrument components and packaging per manufacturing procedures. You will support assembly, inspection, and packaging while upholding safety and GDP standards.

This is a second shift role on a rotating crew (4:00pm–2:30am, Mon-Thu and Tue-Fri). You will document inspections, operate pouch/blister equipment, manage labels, and ensure DHR/ERP accuracy, with a focus on continuous improvement.

Qualifications

• Proficiency with Microsoft Office products and GDP documentation.
• Thorough knowledge of packaging, assembly, inspection, labeling requirements.
• Ability to read and follow work instructions and blueprints.
• Strong documentation and data recording skills.

Responsibilities

• Inspect parts using prints and procedures and document results.
• Assemble, package, and label medical device components in clean room.
• Operate pouch/blister equipment; apply labels and reconcile with records.
• Verify parameters, load units, and inspect sealed products for defects.
• Support line setup, changeovers, and line clearances; maintain ERP/DHR data.

Skills

Microsoft Office

Packaging processes

Read work instructions

Blueprint interpretation

Documentation skills

Education

High School Diploma or GED

Tools

Label dispenser

Label printers

Heat sealers

Crimping machine

Job description

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

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. Ensures that production plan goals are accomplished by supporting production personnel in the assembly, inspection, and packaging of products. Adopt an environment of continuous improvement to develop more robust procedures and improvements within existing processes to produce cost effective quality products. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Second Shift - M-Th, T-Fr, 4:00pm- 2:30am, on a Rotating Crew Schedule

Essential Duties and 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
• Verifies 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.
• 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.

Education and Experience

• 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 / Specialized Courses and/or Training

• 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 work independently when necessary

Machine, Tools, and/or Equipment Skills

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 deal with 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. 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.

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 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 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.