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

Arthrex; Immokalee (FL); On-site; USD 36,000 - 54,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

Company-provided life insurance

401(k) Retirement Plan with company-m

Twice-yearly bonus program

Job summary

Arthrex is seeking an Operations Specialist in Ave Maria, FL to produce quality medical instruments on a rotating second shift. You will support assembly, inspection, packaging, labeling, and data recording in a clean-room environment.

The ideal candidate has a high school diploma, at least 1 year in manufacturing, and the ability to read work instructions, follow GDP documentation, and work well on a team.

Qualifications

• Must be able to read, understand, and follow work instructions.
• Accurate documentation in accordance with GDP and quality systems.
• Experience with packaging processes and visual inspection is preferred.

Responsibilities

• Perform and document inspections on parts per drawings and procedures.
• Assemble and package devices in clean-room setting.
• Record data and apply statistical quality control as required.
• Conduct nondestructive tests to assess material characteristics when needed.
• Apply labels to pouches/blisters and assist in label reconciliation.

Skills

Read/interpret work instructions

Documentation accuracy

Quality inspection

Team communication

Education

High school diploma or equivalent

Tools

Microsoft Excel

Packaging equipment operation

Label printers

Job description

Overview

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

Arthrex is a global medical device company focused on helping surgeons treat their patients better. Arthrex Manufacturing, located in Ave Maria, FL, is 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 customer needs. This role supports production personnel in assembly, inspection, and packaging to help meet production plan goals. The environment emphasizes continuous improvement of procedures to produce cost-effective, quality products.

Responsibilities

• Performs and documents inspections on parts using engineering prints, inspection procedures, or work instructions.
• Performs manual and fixture-assisted device assembly and packaging on medical device components, kits, convenience packs, and other clean-room specific device assembly as assigned.
• Records data and applies statistical quality control procedures.
• Performs nondestructive tests on materials, parts, or products as needed 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 conducts inspections per established work instructions.
• Verifies validated parameters and the use of appropriate tooling.
• Loads and orients unit devices into unit packages and/or automated equipment.
• Inspects assembled and sealed units for defects.
• Assists Production Coordinator/Sr. Production Coordinator with setting up lines.
• Performs daily cleaning, monthly terminal cleaning, and semi-annual terminal cleaning in the clean room.
• Performs supplemental label application, blister loading, pouch and blister sealing, and visual inspection.
• Alerts management to maintenance or repair issues with equipment or tools.
• Assists during changeovers and line setups.
• Follows packaging instructions and work instructions from PLM and Document Management systems based on product structure requirements.
• Manages and segregates scrap.
• Ensures correct and complete assembly of devices.
• Maintains DHR and ERP accuracy and completion.
• Supports QC Hold and/or MRB-related activities.
• Promotes a safe work environment, using PPE as required; communicates issues to management that could cause delays or safety concerns.
• Adheres to all Quality System Requirements.

Qualifications

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

Knowledge, Skills, and Training

• Proficiency with Microsoft Office products is desired.
• Knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements.
• Ability to read, understand, and follow work instructions.
• Ability to interpret blueprints, written specifications, technical documents and protocols, rework addendums, data forms, and packaging/work instructions.
• Accurate documentation skills in accordance with GDP.
• Ability to perform tests and evaluations on materials, products, and processes to measure performance, life, or material characteristics.
• Ability to assess, investigate, and resolve departmental matters.
• Effective written and verbal communication with team members and management.
• Ability to work independently when necessary.

Equipment and Skills

Measuring and test equipment; PC and spreadsheets. Operates label dispenser machines, label printers, heat sealers, crimping machines, weighing scales, peel testing equipment, automated/semi-automated dispensing equipment, arbor press, tygon tube cutter, wire cutters, small hand tools, fixtures, and other clean-room equipment as assigned.

Physical and Environmental Requirements

Reasonable accommodations may be made. The role requires talking or hearing; frequent sitting or standing; use of hands and fingers; reaching with hands and arms. Occasional lifting up to 30 pounds. Visual acuity and close vision requirements apply. Work in a clean room/controlled environment with specified cleaning agents.

Work Location and Schedule

Ave Maria, FL — Second Shift: Monday-Thursday and Tuesday-Friday, 4:00pm–2:30am on a rotating schedule.

Benefits

• Medical, Dental, and Vision Insurance
• Company-provided and Additional Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Onsite Medical Clinics and Lunch
• Tuition Reimbursement
• Paid Parental Leave, PTO, Volunteer PTO
• Employee Assistance Program (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.