Medical Device Assembler Andersen Sterilizers, Inc. Haw River, NC Job Details Full-time $15.50 - $16.00 an hour 22 hours ago Benefits Health insurance Dental insurance 401(k) Vision insurance Life insurance Paid sick time Qualifications Packing Shop math Attention to detail Cleanroom experience FDA regulations Full Job Description Medical Device Assembler Andersen Sterilizers, Inc. is a medical device manufacturer located in Haw River, NC (between Burlington and Chapel Hill. Join our innovative medical manufacturing team as a Medical Device Assembler, where you will play a vital role in the production of high-quality, life-saving medical devices. This position offers an exciting opportunity to work in a dynamic environment focused on precision, quality and compliance with industry standards. As a key contributor, you will be involved in manual and mechanical assembly processes, ensuring that each product meets rigorous safety and performance specifications. Your expertise will help improve patient outcomes worldwide while advancing your career in biomedical manufacturing. Responsibilities Perform manual and mechanical assembly of medical devices according to detailed work instructions and manufacturing standard operating procedures (SOPs). Use precision measurement tools such as calipers, micrometers, and microscopes to verify component dimensions and ensure adherence to specifications. Conduct quality inspections throughout the assembly process, identifying defects or deviations in accordance with quality assurance protocols and FDA regulations. Maintain cleanliness and compliance with

ISO 13485

standards, CGMP (Current Good Manufacturing Practice), and cleanroom protocols to ensure product integrity. Package finished products following packaging procedures while ensuring proper documentation for traceability and compliance. Support continuous improvement initiatives by adhering to manufacturing process improvements and participating in audits or inspections as required. Qualifications Familiarity with

ISO 13485

standards, FDA regulations, GMP (Good Manufacturing Practice), and cleanroom protocols. Ability to perform precise manual assembly tasks with attention to detail and consistency. Basic math skills for measurements, calculations, and documentation accuracy. Prior experience with quality assurance procedures including inspection techniques and defect identification. Comfortable working in a cleanroom environment with adherence to strict safety and cleanliness standards. Join us to contribute your skills to the development of critical medical devices that make a difference worldwide!

Pay:

$15.50 - $16.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid sick time Vision insurance

Work Location:

In person