Senior Medical Device Assembler - Marquee Staffing

Company Overview
Orange County based Medical Techologies is hiring a Medical Device Assembler II Responsibilities

Job Overview

• Perform all product processing from preparation of raw materials to manufacturing of finished goods.
• Can operate all production equipment.
• Assembly of mechanical components, assembly of fluidic systems, inspection, packaging, labeling, parts preparation, cleaning, and assembly.
• Operate microscopes and other analytical instruments.
• Maintain proper documentation for quality and compliance with GMP requirements.
• Complete appropriate paperwork necessary for maintaining good records.
• Utilize clean room, laboratory and manufacturing equipment and special tools and fixtures. Complete all training courses and complete some hands-on trainings.
• Complete required document(s) of the product you produce.
• Interface with personnel within manufacturing and other internal departments.
• Adhere to applicable GMP and ISO rules and regulations
• Able to work independently and as well as a team player.
• Perform miscellaneous task as assigned by supervisor.
• Maintain compliance with Quality System procedures and company policies

Qualifications

• High School diploma and preferably 2-4 years’ experience in medical devices manufacturing.
• Must be familiar with FDA/GMP/GDP regulations.
• Able to read and write English language, work instructions and technical drawings (including schematics), specifications and forms.
• Must be able to use lab equipment and basic hand tools such as microscope, oven, DI water system, sealer, screwdriver, and wrench.
• Must be proficient in using production equipment and computers in the cleanroom.
• Must have the ability to confidently navigate thru QCBD and have an understanding to use QAD Software Systems