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QTS Medical Device Outsourcing · 7 hours ago

Assembler II

US-MN-Bloomington

Full-time

Onsite

New Grad, Entry Level

$19/hr - $22/hr

0+ years exp

QTS Medical Device Outsourcing provides critical end-of-line services for medical device OEMs, focusing on assembly, packaging, and sterilization management. The Assembler II will be responsible for assembling and packaging medical devices and components, ensuring compliance with quality standards and regulations.

Medical Device

Responsibilities

Inspect, assemble, and package medical devices and components

Use tray, band, and impulse sealers

Perform various types of testing on device packaging

Responsible for proper documentation necessary to complete job

Perform material transactions in ERP system

Work with chemicals (Isopropyl Alcohol, solvents, detergents, etc.) as needed to clean work area and components

Assist in weekly cleaning of production areas and common spaces

Ensure products are handled and assembled per QTS Quality Systems Procedures

Move materials to and from the production areas including verification of Part/Lot/Quantity

Adhere to cGMP and ISO regulations

Maintain awareness of workplace safety and relevant training

Handle chemicals and equipment per QTS procedures

Generate and inspect labels per the Standard Operating Procedures (SOPs) for label generation

Participate in the Operational Excellence Program

Other duties as assigned

Qualification

Assembly experienceCleanroom practicesCGMPISO knowledgeOperation of sealersBasic computer skillsHand-eye coordinationVerbalMath skillsAttention to detailOrganizational skillsWritten communication

Required

High school diploma or equivalent

English language (reading comprehension, listening, and writing)

Attention to detail

Good hand-eye coordination

Able to work in a cleanroom environment, including working with chemicals as needed to clean work areas and components (Isopropyl Alcohol, solvents, detergents, etc.)

Proficient in math skills required to complete all manufacturing procedures

Knowledge of Lean Manufacturing Methodologies

Basic computer skills and Microsoft Office proficiency (Outlook, Word, Excel, Teams)

Clear and effective verbal and written communication skills

Organizational skills

Ability to work in a fast-paced team environment

Able to sit and stand for long periods of time

At least 6 months of the following experience: Assembly, manufacturing, and cleanroom experience

Operation of tray, band, and impulse sealers

Knowledge or training pertaining to FDA, cGMP, and ISO regulations

Knowledge or training pertaining to workplace safety and OSHA regulations

Able to accurately measure chemicals/solvents and adjust concentrations as needed

Storing, handling, and cleaning up hazardous materials

Grand Avenue Software (GAS)

Preferred

Able to work overtime as needed (staying later during the week days or at least one weekend day)

Cleaning & Passivation Experience

Cleanroom practices, including gowning

At least 6 months of labeling systems experience

Benefits

401k retirement savings plan with a company match contribution

Onsite health clinics

Discretionary holiday bonus program (based on years of service)

Cretex University

24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost

Wellness program with incentives

Employee death benefit

Employee sick and safe leave

Comprehensive medical insurance with access to virtual providers

Dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider)

Vision insurance

A pre-tax health savings account

Healthcare and dependent care pre-tax reimbursement accounts

Paid holidays

Paid time off

Discretionary profit sharing program

Parental Leave

Accident and critical illness benefits

Optional employee, spouse, and child life

Short and long term disability

Company provided life insurance

Tuition assistance programs