The Association of Technology, Management and Applied Engineering
Operations Specialist- 3rd Shift - (Packaging)- Ave Maria, FL.
The Association of Technology, Management and Applied Engineering, Florida, New York, United States
Job Title:
Operations Specialist – 3rd Shift (Packaging) Location:
Ave Maria, FL.
Company:
Arthrex Inc. (Arthrex Manufacturing) – global medical device company.
Shift:
Sunday – Thursday, 10:00 PM – 6:30 AM.
Overview Produce quality medical instruments in accordance with company procedures and packaging processes. Support production personnel in assembly, inspection, and packaging. Drive continuous improvement to enhance procedures and produce 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 assemblies.
Record data, applying statistical quality control procedures.
Perform nondestructive tests on materials, parts, or products as needed to assess performance, life, or material characteristics.
Print and apply labels onto pouches and blisters; assist in label reconciliation.
Operate pouch and blister sealing equipment and perform inspections per established work instructions.
Verify validated parameters and appropriate tooling usage.
Load and orient unit devices into unit packages and/or automated equipment.
Inspect assembled and sealed units for defects.
Assist Production Coordinator with line setup.
Perform daily, monthly and semi‑annual terminal cleaning activities in the clean room.
Supplemental label application, blister loading, pouch sealing and visual inspection.
Report 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.
Manage and segregate scrap.
Ensure correct and complete assembly of devices.
Maintain DHR and ERP accuracy and completion.
Support QC hold and/or MRB related activities.
Promote safe work environment, use PPE, communicate issues that could delay processes or create safety hazards.
Adhere to all Quality System Requirements.
Education and Experience
High School Diploma or equivalent required.
1 year of manufacturing experience or combination of 1 year manufacturing and 1 year quality control experience.
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, and labeling requirements.
Ability to read, understand, and follow work instructions.
Knowledge of blueprints, technical documents, protocols, rework addenda, data forms, and work instructions.
Accurate documentation skills according to GDP.
Perform tests and evaluations on materials, products, and processes to measure performance, life, or material characteristics.
Investigate and assist in resolving departmental matters.
Effective written and verbal communication with team and management.
Work independently when necessary.
Machine, Tools, and/or Equipment Skills Measuring and test equipment, PC and spreadsheets. Operation of label dispenser, 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 Define problems, collect data, establish facts, draw valid conclusions. Interpret technical instructions in mathematical or diagram form; handle multiple abstract and concrete variables.
Mathematical Skills Apply mathematical principles to job requirements.
Language and Communication Skills Understand and apply language skills required. Communicate ideas and issues verbally to team and management. Write and record data and information per procedures.
Physical Demands Required to talk or hear regularly; sit, use hands and fingers to handle or feel; reach with hands and arms; lift or move up to 30 pounds occasionally.
Vision Requirements Close vision necessary.
Work Environment Clean room and controlled environment; use specified cleaning agents.
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 On‑site Medical Clinics
Free On‑site Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Program (EAP)
EEO Statement 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.
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Operations Specialist – 3rd Shift (Packaging) Location:
Ave Maria, FL.
Company:
Arthrex Inc. (Arthrex Manufacturing) – global medical device company.
Shift:
Sunday – Thursday, 10:00 PM – 6:30 AM.
Overview Produce quality medical instruments in accordance with company procedures and packaging processes. Support production personnel in assembly, inspection, and packaging. Drive continuous improvement to enhance procedures and produce 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 assemblies.
Record data, applying statistical quality control procedures.
Perform nondestructive tests on materials, parts, or products as needed to assess performance, life, or material characteristics.
Print and apply labels onto pouches and blisters; assist in label reconciliation.
Operate pouch and blister sealing equipment and perform inspections per established work instructions.
Verify validated parameters and appropriate tooling usage.
Load and orient unit devices into unit packages and/or automated equipment.
Inspect assembled and sealed units for defects.
Assist Production Coordinator with line setup.
Perform daily, monthly and semi‑annual terminal cleaning activities in the clean room.
Supplemental label application, blister loading, pouch sealing and visual inspection.
Report 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.
Manage and segregate scrap.
Ensure correct and complete assembly of devices.
Maintain DHR and ERP accuracy and completion.
Support QC hold and/or MRB related activities.
Promote safe work environment, use PPE, communicate issues that could delay processes or create safety hazards.
Adhere to all Quality System Requirements.
Education and Experience
High School Diploma or equivalent required.
1 year of manufacturing experience or combination of 1 year manufacturing and 1 year quality control experience.
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, and labeling requirements.
Ability to read, understand, and follow work instructions.
Knowledge of blueprints, technical documents, protocols, rework addenda, data forms, and work instructions.
Accurate documentation skills according to GDP.
Perform tests and evaluations on materials, products, and processes to measure performance, life, or material characteristics.
Investigate and assist in resolving departmental matters.
Effective written and verbal communication with team and management.
Work independently when necessary.
Machine, Tools, and/or Equipment Skills Measuring and test equipment, PC and spreadsheets. Operation of label dispenser, 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 Define problems, collect data, establish facts, draw valid conclusions. Interpret technical instructions in mathematical or diagram form; handle multiple abstract and concrete variables.
Mathematical Skills Apply mathematical principles to job requirements.
Language and Communication Skills Understand and apply language skills required. Communicate ideas and issues verbally to team and management. Write and record data and information per procedures.
Physical Demands Required to talk or hear regularly; sit, use hands and fingers to handle or feel; reach with hands and arms; lift or move up to 30 pounds occasionally.
Vision Requirements Close vision necessary.
Work Environment Clean room and controlled environment; use specified cleaning agents.
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 On‑site Medical Clinics
Free On‑site Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Program (EAP)
EEO Statement 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.
#J-18808-Ljbffr