Senior Machine Operator - (Packaging) - Ave Maria, FL.

Arthrex GmbH; Ave Maria (FL); On-site; USD 42,000 - 54,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

FSA / Flexible Spending Account

Life Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Arthrex Manufacturing in Ave Maria, FL is seeking a Senior Machine Operator (Packaging) to produce quality medical instruments in a compliant, efficient manner. You will support assembly, inspection, and packaging, following PLM and ERP guidelines while maintaining a safe work environment and continuous improvement mindset.

The role requires 1 year of manufacturing experience with packaging and assembly, GMP/DHR knowledge, and the ability to read work instructions.

Qualifications

• High School Diploma or equivalent required.
• At least 1 year of manufacturing experience in assembly or packaging.
• Ability to read and follow work instructions.
• Knowledge of GMP, DHR documentation and GDP.
• Proficient with labeling, packaging and visual inspection processes.

Responsibilities

• Perform device assembly and packaging in a clean room.
• Print and apply labels onto pouches and blisters.
• Operate clean room equipment and automated packaging tools.
• Inspect assembled units and ensure defect-free packaging.
• Manage scrap and material traceability.
• Follow packaging instructions and document accordingly in PLM/DMS.
• Support changeovers and line setups.
• Ensure safety compliance and PPE usage.

Skills

Packaging

Assembly

Labeling

GMPs

DHR/ERP

Documentation

Quality control

Safety PPE

Microsoft Office

Education

High School Diploma or equivalent

Tools

Microsoft Office

Job description

Manufacturing - Ave Maria, FL, US, 34142

Senior Machine Operator - (Packaging) - Ave Maria, FL.

Title: Senior Machine Operator - (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 a Senior Machine Operator 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 customers' needs. The selected individual will ensure 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.

2nd Shift – Monday- Friday, 2:00pm- 10:30pm

Essential Duties and Responsibilities:

• Perform daily, monthly and semi-annual terminal cleaning activities in the clean room.
• 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.
• Print and apply labels onto pouches and blisters. Assist in label reconciliation as needed.
• Perform supplemental label application, blister loading, pouch and blister sealing and visual inspection.
• Operate clean room specific equipment, automated robotic assembly equipment as needed.
• 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.
• Inspect unit assembled and sealed for potential defects.
• 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/Experience:

High School Diploma or equivalent required.

At least 1 year of manufacturing experience required related to assembly and/or packaging of products using manual and mechanized assembly processes.

Knowledge:

Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.

Reasoning Ability:

Develops solutions to a variety of problems of moderate scope and complexity. Refers to work instructions, policies and practices for guidance.

Work is closely supervised. Follows specific, detailed instructions.

Skills:

• Experience with Microsoft Office products desired.
• A thorough knowledge of packaging processes, product assembly, visual inspection, packaging, and labeling requirements.
• Must have the ability to perform tasks by reading, understanding and following work instructions/documents provided.
• Knowledge of and ability to interpret/comprehend written specifications, and packaging and assembly work instructions.
• Knowledge of raw materials, production processes, quality control and other techniques for manufacturing of products.
• Basic understanding of BOMs and Routers and their use for manufacturing.
• Demonstrated understanding of GMPs and DHR content.
• Possess thorough and accurate documentation skills according to GDP for setup and operation of the sealers.
• Understanding of inventory traceability, production processes, inspections, label reconciliation processes, and other techniques for effective manufacturing, distribution, and traceability of products.
• Ability to perform machine setup, verifies validated parameters, determination/ installation and use of appropriate tooling.
• Ability to perform testing.

Reasoning Ability:

Ability to define problems, collects 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; 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.

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.

• 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 Time Off
• 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.